Cristina Saura graduated in Medicine at the Universitat de Barcelona (UB), in 2002 and carried out her training in Medical Oncology at the Vall d’Hebron University Hospital (HUVH), Barcelona. In 2007 she joined HUVH’s Medical Oncology Department directed by Josep Tabernero.
Cristina is Head of HUVH’s Breast Cancer Unit and Principal Investigator of VHIO’s Breast Cancer & Melanoma Group. She presented her research sufficiency project: A programme for early detection of breast cancer in women with high risk: pilot monitoring experience with mammography and Breast MRI, in 2007 obtaining outstanding merit.
To pursue her interests in clinical research, Cristina joined the Program in Clinical Effectiveness at the Harvard School of Public Health in 2007. She obtained her PhD (Cum Laude) from the Autonomous University of Barcelona (UAB) in 2017 for her thesis entitled, Treatment of Breast Cancer diagnosed during pregnancy.
Cristina has participated as Principal Investigator and Co-Investigator in several breast cancer clinical trials. She is actively involved in developing various international studies involving drugs directed against molecular targets in breast cancer. She is especially dedicated to advancing precision oncology and has become a reference in the development of different PI3K inhibitors and anti-HER2 therapies. She is the author of various publications as well as communications at national and international congresses.
Cristina also serves on the Scientific Committee and Board of Directors of the SOLTI academic research group in breast cancer, and is a Member of the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), the Spanish Association of Medical Oncology (SEOM), and GEICAM (Spanish Breast Cancer Research Group).
In 2018, she was awarded with the PERIS recognition by the Generalitat de Catalunya in its strategic plan for research and innovation in health for the project entitled, Precision medicine in metastatic breast cancer: determination of mutations in tumors and circulating tumor ctDNA as tools to guide the treatment of patients with metastatic breast cancer.
The main area of expertise of our Breast Cancer Group, led by Cristina Saura, is clinical research focused on drug development and associated translational research. In addition to maintaining high patient recruitment in our studies, even during the challenging scenario of the COVID-19 pandemic, we also play a leading role in many of the clinical trials that we run. This enables us to apply translational data to guide and accelerate drug development:
Our group focuses on proof-of-concept and proof-of-mechanism clinical trials with targeted therapies, with particular emphasis on cell signaling, cancer stem cells, and immuno- oncology. These include first-in-human studies of targeted therapies, rational combinations of targeted therapies, biomarker-driven trials, and studies in molecularly selected populations.
We link clinical research at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, with different areas of investigation carried out at VHIO, following a truly translational model. For selected projects, we match molecular biology and optimal tumor models with pharmacology and innovative clinical research by involving VHIO scientists in our studies (biomarker development, profound understanding of mechanisms of action and resistance).
We participate in VHIO’s Molecular Prescreening Program, to perform molecular analysis of patients’ tumors. This enables us to select the optimal treatment for our patients with the experimental therapies available in our portfolio of clinical trials.
Importantly, in relation to precision oncology, VHIO is a founding member of both the WIN - Worldwide Innovative Networking in personalized cancer medicine, and the Cancer Core Europe - CCE, consortia. Both are non-governmental organizations that connect international (WIN) and/or European (CCE) cancer centers, including VHIO, to advance cancer diagnostics and therapeutics.
This year, our group and VHIO’s UITM – CaixaResearch, have continued to lead the Basket of Baskets (BoB) trial. This academic study, endorsed by CCE, integrates molecular prescreening, the development of new diagnostic tests such as circulating DNA, with the assessment of targeted therapies in populations of patients who, matched to specific molecular alterations, will be most likely to benefit from these treatments. During 2021, we have also continued to search for funding to add new modules.
In addition, we coordinate the EU-funded Cancer Core Europe Consortium-Building Data Rich Clinical Trials (CCE-DART) project. By harnessing and incorporating powerful cutting-edge technologies, methods and platforms, CCE-DART investigators will spur the design, development, and ringing in of a new generation of data rich, dynamic studies in oncology over the next years to come.
Our Early Drug Development Group and Phase I Unit UITM – CaixaResearch continue to establish VHIO as a leading reference in driving drug development and targeted therapies in oncology. Testament to this are the number of patients who entrust us with their care (551 patients enrolled in phase I and basket studies in 2021), the portfolio of different trials available (207 phase I trials including 27 basket studies in 2021), and the novelty of our programs in precision medicine and immunotherapy drug development. This is also evidenced by our leading role in CCE's Clinical Trials Task Force.
Our BBVA Comprehensive Program of Cancer Immunotherapy & Immunology – CAIMI, continues to expand. This year we have collaborated with Alena Gros, PI of VHIO’s Tumor Immunology & Immunotherapy Group, to initiate our NEXTGEN- TIL trial, evaluating neoantigen selected TILS in epithelial tumors and melanoma, and we have secured funding to start another cellular therapy trial based on NK cells in collaboration with colleagues at the Cancer Center of the Universidad de Navarra (CIMA), in 2022.
We have also fostered important alliances with the pharmaceutical industry and collaborate closely with other clinical research organizations and academic centers of excellence, as well as companies dedicated to advancing personalized cancer medicine and care.
|Code||Clinical Trial Title||Phase|
|CLGK974X2101||A Phase I, open-label, dose escalation study of oral LGK974 in patients with melanoma and breast cancer.||I|
|B7461001||PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS.||I|
|H9H-MC-JBAH||Phase 1 Dose-Escalation Study of LY2157299 Monotherapy and in Combination with Lomustine in Patients with Recurrent Malignant Glioma||I|
|TPU-TAS-120-101||A DOSE-FINDING PHASE 1 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS WITH OR WITHOUT FIBROBLAST GROWTH FACTOR/RECEPTOR (FGF/FGFR)-RELATED ABNORMALITIES FOLLOWED BY A PHASE 2 STUDY IN PATIENTS WITH ADVANCED SOLID TUMORS OR MULTIPLE MYELOMA WITH FGF/FGFR-RELATED ABNORMALITIES||I|
|TED13751||A first-in-human study for the evaluation of the safety, pharmacokinetics and antitumor activity of SAR408701 in patients with advanced solid tumors.||I|
|CINC280X2105C||A phase Ib/II, multicenter,
open-label study of EGF816 in combination with INC280 in adult patients with
mutated non-small cell lung cancer
|MCLA128-CL-01||A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors||II|
|CLDK378A2120C||A multi-center, open-label study to assess the safety and efficacy of combination ceritinib (LDK378) and nivolumab in adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)||I|
|CPDR001X2101-II||Estudio de fase I/II, abierto, multicéntrico, de la eficacia y la seguridad de PDR001 administrado en pacientes con tumores malignos avanzados.||II|
|CA209-358||Non-Comparative, Two-Cohort, Single-Arm, Open-Label, Phase 1/2 Study of Nivolumab (BMS-936558) in Subjects with Virus-Positive and Virus-Negative Solid Tumors.||I|
|CA224-020||A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody Nivolumab, BMS-936558) in Advanced Solid Tumors||I|
|BAY 2757556 (LOXO-TRK-15002)||A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors||II|
|B9991005||A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.||I|
|MK-3475-158||Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158)||II|
|I5B-MC-JGDL||A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma||I|
|MM-398-07-02-03||A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (nal-IRI)-containing Regimens versus nab-Paclitaxel plus Gemcitabine in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma.||I|
|PCYC-1128-CA||A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors||I|
|EMR200647-001 (TRAP001)||Ensayo de fase I, abierto, con dosis múltiples ascendentes, para investigar la seguridad, tolerabilidad, farmacocinética, y actividad biológica y clínica de MSB0011359C en sujetos con tumores sólidos metastásicos o localmente avanzados y expansión a indicaciones seleccionadas||I|
|CC-90010-ST-001||A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-90010 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY NON-HODGKIN?S LYMPHOMAS||I|
|CLXH254X2101||A phase I dose finding study of oral LXH254 in adult patients with advanced solid tumors harboring MAPK pathway alterations.||I|
|CPDR001X2102||Phase Ib, open-label,
multi-center study to characterize the safety, tolerability and
pharmacodynamics (PD) of PDR001
in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) .
|I8X-MC-JECA||A Phase 1 Study of LY3200882 in Patients with Solid Tumors.||I|
|GO30103 (FELIX)||"A PHASE Ia/Ib OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF MTIG7192A AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC TUMORS"||I|
|CFAZ053X2101||A phase I, open-label,
multi-center dose escalation study of FAZ053 as single agent and in
combination with PDR001 in
adult patients with advanced malignancies.
|H3B-6527-G000-101||An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma||I|
|CA017-003-II||A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal Antibody) in Advanced Malignant Tumors.||II|
|204691( ICOS )||A Phase I Open Label Study of
GSK3359609 Administered Alone and in Combination with Anticancer Agents in
with Selected Advanced Solid Tumors.
|RXDX-101-02 (STARTRK-2)||An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements.||II|
|63723283LUC1001||A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers.||I|
|WIN001 (SPRING)||Survival Prolongation by Rationale INnovative Genomics (SPRING): A proof of concept study to explore safety and efficacy of tri-therapy approach in advanced/metastatic NSCLC and retrospectively assess the ability of integrated genomics and transcriptomics to match patients to the combination.||I|
|1280.18||An open label, phase Ib,
dose-escalation study evaluating the safety and tolerability of xentuzumab
and abemaciclib in patients with locally advanced or metastatic solid tumours
and in combination with endocrine therapy in patients with locally
advanced or metastatic hormone receptor-positive, HER2-, breast cancer, followed by expansion cohorts.
|D419NC00001||A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects with Select Advanced Solid Tumors.||I|
|GO39374||A PHASE I, OPEN-LABEL,
DOSE-ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND
PHARMACOKINETICS OF GDC-0077 AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE AND TARGETED THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT HORMONE-RECEPTOR POSITIVE BREAST CANCER
|CPDR001C2101||Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1unselected, metastatic NSCLC patients||I|
|BAY94-9343/15834||Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with mesothelin expressing advanced or recurrent malignancies.||I|
|VHIO-PBF-999-01||"Phase I/Ib trial of single agent PBF-999 in solid tumour advanced cancer"||I|
|CTNO155X2101||An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors||I|
|MK-4280-001||"A Phase 1 Trial of MK-4280 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors"||I|
|PM14-A-001-17||Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors||I|
|4010-01-001||A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors||I|
|CP-MGA012-01||A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of MGA012 in Patients with Advanced Solid Tumors.||I|
|W00101 IV 1 01||Phase I/II open label dose escalation and dose expansion study of intravenous infusion of W0101, an antibody-drug conjugate, in patients with advanced or metastatic solid tumors International, multicenter, open label study.||I|
|CNIR178X2201||A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma.||II|
|WO39608 (MORPHEO 1)||A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (MORPHEUS-PANCREATIC CANCER).||I|
|CB103-C-101||A PHASE I/IIA, MULTI-CENTRE, OPEN-LABEL, DOSE-ESCALATION STUDY WITH EXPANSION ARMS TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CB-103 ADMINISTERED ORALLY IN ADULT PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMOURS AND HAEMATOLOGICAL ALIGNANCIES CHARACTERISED BY ALTERATIONS OF THE NOTCH SIGNALLING PATHWAY .||I|
|CLHC165X2101||A Phase I/Ib, open-label, multi-center dose-escalation and dose-expansion study of the safety and tolerability of intratumorally administered LHC165 single agent and in combination with PDR001 in patients with advanced malignancies.||I|
|ARRAY-162-202||An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination with Nivolumab or Nivolumab Plus Ipilimumab in Patients with Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer with RAS Mutation||I|
|BLU-667-1101||A Phase 1 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors.||I|
|CDRB436X2X02B||An open label, multi-center
roll-over study to assess longterm safety in patients who are ongoing or have
a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment.
|C0541001||A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS.||I|
|BAY 1163877 / 19131||An international, multicenter, Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab as first-line treatment in cisplatin-ineligible patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.||I|
|64091742PCR2002||A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer.||I|
|BO39610||A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MORPHEUS-LUNG).||I|
|AG270-C-001||A Phase 1 Study of AG-270 in the Treatment of Subjects with Advanced Solid Tumors or Lymphoma with Homozygous Deletion of MTAP.||I|
|1401-0001||An open-label, Phase I trial to determine the maximum-tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 905677 administered intravenously in patients with advanced solid tumours.||I|
|GO39733||A PHASE IA/IB OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF RO7198457 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC TUMORS.||I|
|XL184-021||A Phase 1b Dose Escalation Study of Cabozantinib (XL184) Administered in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors.||I|
|B9991023||A MULTICENTER, OPEN-LABEL, PHASE 1B/2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED MALIGNANCIES.||I|
|BP40087||AN OPEN-LABEL, MULTICENTER,
DOSE-ESCALATION, PHASE IA/IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND
PRELIMINARY ANTI-TUMOR ACTIVITY OF RO7122290, A FIBROBLAST ACTIVATION
PROTEIN-a (FAP) TARGETED 4-1BB LIGAND (CD137L), WITH OR WITHOUT OBINUTUZUMAB PRE-TREATMENT, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS AS SINGLE AGENT OR IN COMBINATION WITH ATEZOLIZUMAB FOLLOWED BY TUMOR SPECIFIC EXPANSION COHORT(S).
|GO39932||"A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC 9545 Alone or In Combination with Palbociclib and/or LHRH Agonist in Patients with Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer"||I|
|CO40115||"A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE NEGATIVE BREAST CANCER (MORPHEUS TNBC)"||I|
|IO102-012(KN-764)||An Open-label, Randomized, Phase I/II Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer.||I|
|CA022-001||Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors.||I|
|MEN1611-01(B PRECISE 01)||OPEN-LABEL, MULTICENTER, PHASE IB DOSE-ESCALATION STUDY OF MEN1611, A PI3K INHIBITOR COMBINED WITH TRASTUZUMAB ± FULVESTRANT, IN SUBJECTS WITH PIK3CA MUTATED HER2-POSITIVE LOCALLY RECURRENT UNRESECTABLE (ADVANCED) OR METASTATIC (A/M) BREAST CANCER PROGRESSED TO ANTI-HER2 BASED THERAPY .||I|
|LOXO-EXT-17005||A Phase 1/2 Study of the TRK
Inhibitor LOXO-195 in Adult and Pediatric Subjects with Previously Treated
|BP40234||AN OPEN-LABEL, MULTICENTER, PHASE II STUDY TO EVALUATE THE THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGETING FIBROBLAST ACTIVATION PROTEIN-Α (FAP), IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1), ADMINISTERED INTRAVENOUSLY, IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||II|
|LOXO-RET-17001||"A Phase 1 Study of Oral LOXO-292 in Adult Patients with Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medularry Thyroid Cancer, and Other Tunors with Increased RET Activity".||I|
|GCT1029-01||First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors.||I|
|BGB-290-103||A Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumors.||I|
|204686||"A Phase I, Open-Label Study of GSK1795091 Administered in Combination with Immunotherapies in Participants with Advanced Solid Tumors"||I|
|MCLA-158-CL01||Phase 1 dose escalation and cohort expansion study evaluating single-agent MCLA-158 in metastatic colorectal cancer and other advanced solid tumors.||I|
|64619178EDI1001||A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects with Advanced Cancers.||I|
|Brigatinib-1001||A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors.||I|
|CC-90011-ST-001||A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-90011 IN SUBJECTS WITH RELAPSED AND/OR REFRACTORY SOLID TUMORS AND NON-HODGKIN’S LYMPHOMAS.||I|
|IOV-COM-202||A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors.||II|
|BP40657||A RANDOMIZED, MULTICENTER, PHASE Ib/III STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS COMPARED WITH ATEZOLIZUMAB INTRAVENOUS IN PATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.||I|
|J1F-MC-JZFA||A Phase 1a/1b Study of LY3405105 Administered to Patients with Advanced Solid Tumors.||I|
|VHIO17002 (MO39164)||Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.||II|
|D8530C00001||A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast CancerA Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast Cancer.||I|
|C2321001||A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL).||I|
|ACT15377||Estudio en fase 1/2, abierto, multicéntrico, para evaluar la seguridad, eficacia preliminar y farmacocinética de isatuximab (SAR650984) en combinación con atezolizumab o solo isatuximab en pacientes con enfermedades malignas avanzadas||I|
|INCB01158-101||Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (formerly known as CB-1158) as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with vanced/Metastatic Solid Tumors.||I|
|2102-ONC-102||A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation.||I|
|GEIS 58 (OLATRASTS)||"Ensayo clínico de fase I con Olaratumab más Trabectedina en pacientes con sarcoma de tejidos blandos avanzado"||I|
|CA209-848||A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H).||II|
|CO40939||A PHASE Ib, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMAKOKINETICS OF RO6958688 IN COMBINATION WITH ATEZOLIZUMAB AFTER PRETREATMENT WITH OBINUTUZUMAB IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC, MICROSATELLITE-STABLE COLORECTAL ADENOCARCINOMA WITH HIGH CEACAM5 EXPRESSION.||I|
|CADPT01A12101C||A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select immunotherapy combinations in adult patients with triple negative breast cancer.||I|
|YO40482||A PHASE Ib STUDY OF COBIMETINIB ADMINISTERED IN COMBINATION WITH NIRAPARIB, WITH OR WITHOUT ATEZOLIZUMAB, TO PATIENTS WITH ADVANCED PLATINUM-SENSITIVE OVARIAN CANCER.||I|
|MK-7339-002||A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer.||II|
|SGNTV-001||Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors.||II|
|61186372EDI1001||A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small Cell Lung Cancer.||I|
|B9991032||A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS.||II|
|ICO-VCN-H&N-2018||A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck.||I|
|WO39613||A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC).||I|
|A206T-G01-001 (PROTER)||A Phase 1/2 open-label,
multi-center, dose-escalation study of safety, tolerability,
pharmacokinetics, dosimetry, and response to repeat dosing of 177Lu-PSMA-R2
radio-ligand therapy in patients with prostate specific membrane antigen
(PSMA) positive (68Ga-PSMA-R2) progressive metastatic castration-resistant
prostate cancer, following previous systemic
dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in
with malignant solid tumors.
|BP40657-III||A RANDOMIZED, MULTICENTER, PHASE Ib/III STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS COMPARED WITH ATEZOLIZUMAB INTRAVENOUS IN ATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER||III|
|CP-MGD013-01||A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms.||I|
|BO40933||A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF IPATASERTIB IN COMBINATION WITH RUCAPARIB IN PATIENTS WITH ADVANCED BREAST, OVARIAN, OR PROSTATE CANCER.||I|
|ZEN003694-004||A Phase 2 Study of ZEN003694 in Combination with Talazoparib in Patients with Triple-Negative Breast Cancer.||I|
|D7980C00001 (MEDI5752)||A Phase 1, Open-label,
Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability
Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects with Advanced Solid Tumors.
|20140318 (MASTERKEY-318)||A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318).||II|
|8374-CL-0101||A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors.||I|
|NBTXR3-102||ESTUDIO DE FASE I DE AUMENTO ESCALONADO/AMPLIACIÓN DE LA DOSIS DE NBTXR3 ACTIVADO MEDIANTE RADIOTERAPIA DE INTENSIDAD MODULADA EN PACIENTES CON CARCINOMA DE CÉLULAS ESCAMOSAS LOCALMENTE AVANZADO EN LA CAVIDAD BUCAL O LA OROFARINGE.||I|
|Debio 1143-106||SMARTPLUS-106: Debio 1143 a SMAC Mimetic In Combination With Nivolumab In Patients Failing Prior PD-1/PD-L1 Treatment: A Basket Trial. A dose-optimization, exploratory phase Ib/II study to assess safety and efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) mimetic Debio 1143, when given in combination with the anti-PD-1 antibody nivolumab in patients with specific solid tumors who have progressed during or immediately after anti-PD-1/PD-L1 treatment.||II|
|SC103||A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors.||I|
|XL184-021 (PULMON)||A Phase 1b Dose Escalation Study of Cabozantinib (XL184) Administered in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors.||I|
|BP41054||AN OPEN-LABEL, MULTICENTER, PHASE IB STUDY TO EVALUATE SAFETY AND THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGETING FIBROBLAST ACTIVATION PROTEIN-Α (FAP), IN COMBINATION WITH PEMBROLIZUMAB (ANTI-PD-1), IN PARTICIPANTS WITH PREVIOUSLY UNTREATED ADVANCED AND/OR METASTATIC MELANOMA.||I|
|208850 (STING)||A Phase I First Time in Human Open Label Study of GSK3745417 administered with and without Anticancer Agents in Participants with Advanced Solid Tumors.||I|
|TCD14678||A Phase 1/1b first-in-human dose
escalation and expansion study for the evaluation of safety,
pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR439459
administered intravenously as monotherapy and in combination
with cemiplimab in adult patients with advanced solid tumors.
|CLXH254X2102||A Phase Ib, open-label,
multicenter study of oral LXH254- centric combinations in adult patients with
metastatic KRAS or BRAF mutant Non-Small Cell Lung Cancer or NRAS mutant melanoma.
|CTNO155B12101||A Phase Ib, open-label,
multi-center study to characterize the safety, tolerability, and preliminary
efficacy of TNO155
in combination with spartalizumab or ribociclib in selected malignancies.
|207675||A phase I, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3368715 in participants with solid tumors and DLBCL.||I|
|CP-MGC018-01||A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation of Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) alone and in combination with MGA012 (Anti-PD-1 Antibody) in Patients with Advanced Solid Tumors.||I|
|M19-037||A Phase 1, Multi-Center, Open Label, Dose-Escalation Study to Determine the Safety, Tolerability and Pharmacokinetics of ABBV-927 and ABBV-368 with and without ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumor.||I|
|LOXO-RET-18037||A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201).||I|
|1336-0011||An open label phase Ib dose
finding study of BI 836880 in combination with BI 754091 to characterize
pharmacokinetics, pharmacodynamics and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and in other solid tumors.
|CL1-95012-001||“Estudio de primera administración en humanos de fase I/II, abierto, multicéntrico, de escalada de dosis y expansión con PRS-344/S095012 en pacientes con tumores sólidos”||I|
|1426-0001||Phase I, first in human trial evaluating BI 1387446 alone and in combination with BI 754091 in solid tumors.||I|
|ASTX029-01||A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors.||I|
|SGN228-001||A phase 1 study of SGN-CD228A in subjects with select advanced solid tumors.||I|
|MS201922-0001||An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-803/M4344 as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors.||I|
|42756493CAN2002/ODIN (RAGNAR)||A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations.||II|
|NP40435||AN OPEN LABEL, MULTICENTER, DOSE ESCALATION AND EXPANSION, PHASE 1 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY ANTI TUMOR ACTIVITY OF RO7121661, A PD-1/TIM-3 BISPECIFIC NTIBODY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||I|
|CNTO1959COR1001||A Phase 1b, Multicenter,
Randomized, Blinded, Placebo-controlled Study to Evaluate the
Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis.
|20180290||A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects with MUC17-Positive Gastric and Gastroesophageal Junction Cancer.||I|
|CPDR001X2X01B||An open-label, multi-center
rollover protocol for continued characterization of safety and tolerability
for subjects who
have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments.
|GCT1021-01||First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax®-AXL-ADC) in patients with solid tumors.||I|
|U31402-A-U102||A MULTICENTER, OPEN-LABEL PHASE
1 STUDY OF U3-1402 IN SUBJECTS WITH METASTATIC OR
UNRESECTABLE NON-SMALL CELL LUNG CANCER.
|NP41300||AN OPEN LABEL, MULTICENTER, DOSE ESCALATION, PHASE 1 STUDY TO EVALUATE SAFETY/TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY ANTI TUMOR ACTIVITY OF RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||I|
|CNIZ985B12101||A Phase I/Ib Study of Subcutaneous Recombinant NIZ985 ((het-IL-15) (IL-15/sIL-15Rα)) in combination with Spartalizumab in adults with check point inhibitor (CPI) relapsed advanced malignancies.||I|
|SOLTI-1507 (IPATHER)||A phase Ib study of Ipatasertib, an AKT inhibitor, in combination with Pertuzumab plus Trastuzumab in patients with PI3KCA-mutant, HER2-positive locally advanced or metastatic breast cancer (IPATHER)||I|
|INCB 54828-207||A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207).||II|
|2455-002||An Open-label, Phase 1 Study of KHK2455 in Combination with Avelumab in Adult Subjects with Locally Advanced or Metastatic Urothelial Carcinoma.||I|
|WP41188||AN OPEN LABEL, MULTICENTER, DOSE ESCALATION AND EXPANSION, PHASE 1 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY ANTI TUMOR ACTIVITY OF RO7296682, A CD25-TARGETING, T-REGULATORY CELL DEPLETING ANTIBODY IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS||I|
|SL01-DEL-101||Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects with Advanced Solid Tumors or Lymphomas.||I|
|WP41377||A FIRST IN HUMAN, OPEN LABEL, DOSE ESCALATION PHASE I STUDY EVALUATING SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ACTIVITY PROFILE OF SINGLE AGENT RO7119929 (TLR7 AGONIST 4 ASIP) ADMINISTERED ORALLY TO PARTICIPANTS WITH UNRESECTABLE ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA, BILIARY TRACT CANCER, OR SOLID TUMORS WITH PREDOMINANTLY HEPATIC METASTASES.||I|
|73841937NSC2001||A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC).||I|
|CKAZ954A12101||A phase I/Ib, open-label, multi-center, study of KAZ954 as a single agent and in combination with Spartalizumab, NZV930 and NIR178 in patients with advanced solid tumors.||I|
|EOGBM1-18||A MulticenteR, Open-Label, First-in-Human, PhaSe Ib/IIa Trial of EO2401, a Novel Multipeptide Therapeutic VAccine, with and without PD-1 Check Point Inhibitor, FoLlowing Standard Treatment in PatIents with ProgrEssive Glioblastoma (Rosalie study).||I|
|AFM24-101||A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers.||I|
|BAY88-8223/19781||An open-label, multicenter, Phase 1/2 study of radium-223 dichloride in combination with pembrolizumab in participants with stage IV non-small cell lung cancer.||I|
|CV-8102-008||Phase I study of intratumoral CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.||I|
|1412-0001||A first-in-human phase Ia/b, open label, multicentre, dose escalation study of BI 905711 in patients with advanced gastrointestinal cancers.||I|
|IMC-C103C-101||A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A*0201-positive Patients with Advanced MAGE-A4-positive Cancer.||I|
|J2J-MC-JZLA||A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer.||I|
|208471||A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T-Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer.||I|
|CC-90011-SCLC-001||A PHASE 1B, MULTICENTER, OPEN-LABEL, DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF CC-90011 GIVEN IN COMBINATION WITH CISPLATIN AND ETOPOSIDE TO SUBJECTS WITH FIRST LINE, EXTENSIVE STAGE SMALL CELL LUNG CANCER.||I|
|2SMALL||Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with Platinum-Based Chemotherapy.||I|
|GCT1044-01||First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1044 in subjects with malignant solid tumours.||I|
|EOADR1-19 (SPENCER)||A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma.||I|
|GO40311||A PHASE Ia/b, OPEN-LABEL,
DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS
OF BTRC4017A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT AND IN COMBINATION WITH
TRASTUZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HER2-EXPRESSING CANCERS.
|CO41863||A PHASE Ib/II, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF VENETOCLAX IN COMBINATION WITH TRASTUZUMAB EMTANSINE (T-DM1) IN PREVIOUSLY TREATED HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER PATIENTS.||I|
|CC-90010-GBM-002||A PHASE 1B, OPEN-LABEL,
DOSE-FINDING STUDY OF CC-90010 IN COMBINATION WITH TEMOZOLOMIDE
WITH OR WITHOUT RADIATION THERAPY IN SUBJECTS WITH NEWLY DIAGNOSED GLIOBLASTOMA.
|208750||Seguimiento a largo plazo de los participantes expuestos a GSK3377794 (NY-ESO-1c259 T), un receptor de linfocitos T específicos de NY-ESO-1 modificado genéticamente.||I|
|BP41628||AN OPEN LABEL, MULTICENTER,
RANDOMIZED DOSEESCALATION AND EXTENSION, PHASE IA/IB STUDY TO
EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF RO7284755, A PD-1 TARGETED IL-2 VARIANT (IL-2V) IMMUNOCYTOKINE, ALONE OR IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.
|BNT411-01||Phase 1/2a, first-in-human,
open-label, dose-escalation trial with expansion cohorts to evaluate safety,
pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer
|CO41792||A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND DOCETAXEL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER.||I|
|ODO-TE-S101||An Open-Label Study of the Effect of Tesetaxel on the QTc Interval and the Effect of Food,Itraconazole,and Rifampinon Tesetaxel Pharmacokinetics in Patients with Advanced Solid Tumors.||I|
|1438-0001||A First–in-human Phase I, non-randomized, open-label, multicenter dose escalation trial of BI 764532 administered by repeated intravenous infusions in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.||I|
|M19-611||A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer.||I|
|4020-01-001 (AMBER)||A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER).||I|
|ICT01-101||A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study).||I|
|DCC-3014-01-001||A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors.||I|
|D6770C00001||Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination with Durvalumab ± Oleclumab in Advanced Solid Tumors.||I|
|Uni-Koeln-1784 (EATON)||An open-label, multicenter, phase I dose-escalation trial of EGF816 and trametinib in patients with non-small cell lung cancer and acquired EGFR p.T790M positive resistance to 1st or 2nd generationEGFR TKI therapy.||I|
|DEBIO 1143-106-II||SMARTPLUS-106: Debio 1143 a SMAC Mimetic In Combination With Nivolumab In Patients Failing Prior PD-1/PD-L1 Treatment: A Basket Trial. A dose-optimization, exploratory phase Ib/II study to assess safety and efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) mimetic Debio 1143, when given in combination with the anti-PD-1 antibody nivolumab in patients with specific solid tumors who have progressed during or immediately after anti-PD-1/PD-L1 treatment.||II|
|70218902EDI1001||A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors.||I|
|Debio 0123-101||A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors.||I|
|20180292||A Global Phase 1 Study Evaluating the Safety,Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.||I|
|CBLZ945X2101||A phase I/II, open-label, multi-center study of the safety and efficacy of BLZ945 as single agent and in combination with PDR001 in adults patients with advanced solid tumors.||I|
|MEN1611-02 (C-PRECISE-01)||OPEN-LABEL,MULTICENTRE, PHASE IB/II STUDY OF MEN1611, A PI3K INHIBITOR, AND CETUXIMAB IN PATIENTS WITH PIK3CAMUTATED METASTATIC COLORECTAL CANCER FAILING IRINOTECAN, OXALIPLATIN, 5-FU AND ANTI-EGFR CONTAINING REGIMENS.||I|
|V937-013||Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic Solid Tumors.||I|
|GO41751||A PHASE I, OPEN-LABEL, DOSE-ESCALATION PHARMACOKINETICS OF BLYG8824A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC COLORECTAL CANCER.||I|
|LOXO-IDH-20002||A Phase 1 Study of LY3410738 Administered to Patients with Advanced Solid Tumors with IDH1 R132 Mutations.||I|
|GCT1042-01||A First-in-Human, Open-label, Dose-escalation Trial with Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects with Malignant Solid Tumors.||I|
|NOCANTHER||A feasibility clinical
investigation of intratumoral injection of magnetic nanoparticles associated
to hyperthermia treatment
in locally advanced pancreatic cancer.
|D967VC00001(DESTINY-PanTumor02)||Phase 2, Multicentre, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors .||II|
|PM1183-A-017-20||An Open-Label, Multicenter, Pharmacokinetic Study of Lurbinectedin in Patients with Advanced Solid Tumors and Varying Degrees of Hepatic Impairment.||I|
|AFM24-101-II||A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers.||II|
|D967MC00001 (DESTINY)||Phase II, multicenter, open-label study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of unresectable and/or metastatic solid tumors harboring HER2 activating mutations regardless of tumor histology.||II|
|CK-301-101||A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects with Advanced Cancers.||I|
|SGNTGT-001||A Phase 1 Study of SGN-TGT in Subjects with Advanced Malignancies.||I|
|73841937NSC1001||An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer.||I|
|D967LC00001(DESTINY 3)||A Phase 1b/2 Multicenter,
Open-label, Dose-escalation and Doseexpansion Study to Evaluate the Safety,
Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and
Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer (DESTINY-Gastric03).
|213152||A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer with Disease Progression or Recurrence Following Treatment with a Platinun agent.||I|
|BT8009-100 (BICYCLE)||Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies.||I|
|ACT16432||Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of SAR408701 in patients with CEACAM5-positive advanced solid tumors.||II|
|CADPT01C12101||A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select drug combinations in adult patients with advanced or metastatic BRAF V600 colorectal cancer.||I|
|CJDQ443A12101||A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation.||I|
|TAS-120-202||A Phase 2 Study of Futibatinib in Patients with Specific FGFR Aberrations.||II|
|GO42144||A PHASE I DOSE-ESCALATION AND DOSE-EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC 6036 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION.||I|
|ABT-C11-2020||A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer.||I|
|BP42169||AN OPEN-LABEL, MULTICENTER, PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7293583, A TYRP1-TARGETING CD3 T-CELL ENGAGER, IN PARTICIPANTS WITH METASTATIC MELANOMA.||I|
|BP42595||AN OPEN-LABEL, MULTICENTER PHASE 1b STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7296682 IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||I|
|DZB-CS-202 (BASILEA)||Phase 1b/2 study of derazantinib as monotherapy and combination therapy with paclitaxel, ramucirumab or atezolizumab in patients with HER2-negative gastric adenocarcinoma harboring FGFR genetic aberrations (FIDES-03).||I|
|SGNB6A-001||A Phase 1 Study of SGN-B6A in Advanced Solid Tumors.||I|
|CA030-001||A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors.||II|
|MS200647_0046||Safety Study of Bintrafusp alfa in Combination with Other Anti-cancer Therapies in Participants with Locally Advanced or Advanced Cervical Cancer.||I|
|R6569-ONC-1933||A Phase 1 Study of REGN6569, an Anti-GITR mAb, with Cemiplimab in Patients with Advanced Solid Tumor Malignancies.||I|
|D9720C00001(PETRA)||A Modular Phase I/IIa, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5305 monotherapy and in combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies.||I|
|BP42675||AN OPEN LABEL, MULTICENTER, PHASE IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI TUMOR ACTIVITY OF CIBISATAMAB IN COMBINATION WITH RO7122290, A FIBROBLAST ACTIVATION PROTEIN A (FAP) TARGETED 4 1BB LIGAND (CD137L), WITH OBINUTUZUMAB PRE TREATMENT, IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC, MICROSATELLITE-STABLE COLORECTAL ADENOCARCINOMA WITH HIGH CEACAM5 EXPRESSION.||I|
|OMO-103-01(OMOMYC)||A Phase 1/2 Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 administered intravenously in Patients with Advanced Solid Tumours.||I|
|2020-306-GLOB2||MULTICENTER, OPEN-LABEL PHASE I
STUDY EVALUATING THE SAFETY AND TOLERABILITY OF HMPL-306 IN SUBJECTS WITH
LOCALLY ADVANCED OR METASTATIC SOLID TUMORS.
WITH IDH MUTATIONS
|CTL-002-001||A PHASE I, FIRST IN HUMAN, TWO PART, OPEN-LABEL CLINICAL TRIAL OF INTRAVENOUS ADMINISTRATION OF CTL-002 GIVEN AS MONOTHERAPY AND/OR IN COMBINATION WITH AN ANTI-PD-1 CHECKPOINT-INHIBITOR IN SUBJECTS WITH ADVANCED STAGE, RELAPSED/REFRACTORY SOLID TUMORS.||I|
|FS222-19101 (F-STAR)||A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects with Advanced Malignancies.||I|
|CDKY709A12101C||A phase I, open-label, multi-center, study of DKY709 as a single agent and in combination with spartalizumab in patients with advanced solid tumors,||I|
|1367.1||An open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies, with repeated administration in patients with clinical benefit.||I|
|20180143||A Phase 1 Study to Evaluate Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients With Advanced Solid Tumors.||I|
|CTMX-M-2029-001 (PROCLAIM-CX-2029)||A Phase 1-2, First-in-Human
Study of CX-2029 in Adults with Metastatic or Locally Advanced Unresectable
Solid Tumors or
Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029).
|CO42867||Phase 1b/II umbrella, adaptive
The first cohort of the new Breast Cancer study will target 2L or 3L metastatic or inoperable locally advanced ER+ Breast Cancer patients who had disease progression during or following treatment with a CDK4/6i.
|AGI-134.FIM.101||A PHASE I/IIA, MULTICENTRE, TWO-PARTS, OPEN-LABEL STUDY DESIGNED TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF AGI-134 GIVEN IN UNRESECTABLE/METASTATIC SOLID TUMOURS||I|
|VHIO20001 (NEXTGEN-TIL-ACT)||A Phase I study to assess the safety and tolerability of ex vivo neoantigen-selected Tumor-infiltrating Lymphocytes (TILs) in advanced epithelial tumors and refractory melanoma.||I|
|1472-0001||A Phase Ia/Ib, open-label, multicentredose-escalation and expansion study to investigate the safety, pharmacokinetics and preliminary efficacy of BI 1823911 as a monotherapy and in combination with other anti-cancer therapies in patients with advanced or metastatic solid tumoursexpressing KRAS G12C mutation.||I|
|20180144||A Phase 1 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients with Advanced Solid Tumors.||I|
|BNT151-01||Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT151 as a monotherapy and in combination with other anti-cancer agents in patients with solid tumors.||I|
|20160323 (AMG757)||A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer.||I|
|SOLTI-1904 (ACROPOLI)||EfficACy of Spartalizumab acROss
multiPle cancer-types in patients with PD1-high
mRNA expressing tumOrs defined by a singLe and pre-specIfied cutoff (ACROPOLI trial).
|D933IC00001(MAGELLAN)||A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN).||I|
|D9570C00001||A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, anti-TIM-3 and anti PD-1 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors .||I|
|SGNSTNV-001||A Phase 1 Study of SGN-STNV in Advanced Solid Tumors.||I|
|WP42627||AN OPEN LABEL, MULTICENTER, DOSE-ESCALATION AND EXPANSION, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND ANTI-TUMOR ACTIVITY OF RO7300490, A FIBROBLAST ACTIVATION PROTEIN-á (FAP) TARGETED CD40 AGONIST, AS SINGLE AGENT OR IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||I|
|NLM-2020-01(NELUM-NLM)||Phase Ib/IIa Study to evaluate safety and efficacy of Priming Treatment with the Hedgehog Inhibitor NLM-001 Prior to Chemotherapy (Gemcitabine and Nab-Paclitaxel) plus AGEN 1884 as First Line treatment in Patients with Advanced Pancreatic Cancer.||I|
|Sym021-02||An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination with Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients with Advanced Solid Tumor Malignancies.||I|
|M20-111||A Phase 1 first in human study evaluating safety and efficacy of ABBV-637 monotherapy and combined with docetaxel in adult subjects with relapsed and refractory solid tumors.||I|
|BO41932||TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL.||II|
|ACT16845||Estudio de fase 2 no aleatorizado, abierto, multicéntrico y de múltiples cohortes que evalúa el beneficio clínico de SAR444245 (THOR-707) en combinación con cemiplimab para el tratamiento de participantes con cáncer avanzado de piel irresecable o metastásico||I|
|MK-6482-016||An Open-label, Multicenter, Phase 2 Study of Pembrolizumab Plus Lenvatinib in Combination With MK-6482 in Multiple Solid Tumors.||II|
|CIAG933A12101||“Estudio de fase I, multicéntrico y abierto de IAG933 oral en pacientes adultos con mesotelioma avanzado y otros tumores sólidos”||I|
|CO42800||"A PHASE IB, OPEN-LABEL,
DOSE-ESCALATION AND DOSEEXPANSION
STUDY EVALUATING THE SAFETY,
TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY
ANTI-TUMOR ACTIVITY OF INAVOLISIB IN COMBINATION WITH
PACLITAXEL AND WITH OR WITHOUT TARGETED THERAPIES
IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC
|CAN04CLIN003||A PHASE 1B DOSE ESCALATION AND EXPANSION STUDY OF CAN04, A MONOCLONAL ANTIBODY TARGETING IL1RAP, IN COMBINATION WITH MODIFIED FOLFIRINOX IN SUBJECTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA.||I|
|MK-3475-B98 (KEYNOTE-B98)||A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Investigational Agents for the Treatment of Participants With PD-1/L1-refactory Extensive Stage Small Cell Lung Cancer in Need of Second-Line Therapy.||I|
|D9950C00001||A Phase I First-in-human Study
to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of
Administered Intravenously as Monotherapy and in Combination With Durvalumab (MEDI4736) in Participants With Advanced Solid Tumours.
|WO42758 (INTRINSIC)||A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC).||I|
|DS1062-A-U102 (Tropion- Lung02)||“Phase 1b, Multicenter, Open-label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Pembrolizumab with or without Platinum Chemotherapy in Subjects with Advanced or Metastatic NonSmall Cell Lung Cancer (Tropion-Lung02)”||I|
|EZH-108||A PHASE I, OPEN-LABEL MULTI-DOSE
TWO-PART STUDY TO CHARACTERIZE THE EFFECTS OF A
STRONG CYP3A4 INHIBITOR ON THE STEADYSTATE PHARMACOKINETICS OF TAZEMETOSTAT (EPZ-6438), AND THE EFFECTS OF A STRONG CYP3A4 INDUCER ON THE STEADY-STATE PHARMACOKINETICS OF AZEMETOSTAT IN SUBJECTS WITH ADVANCED MALIGNANCIES.
|20190136||A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects with Advanced Solid Tumors.||I|
|78306358STM1001||A Phase 1, First-in-Human, Dose Escalation Study of JNJ-78306358 in Participants with Advanced Stage Solid Tumors.||I|
|CAN04CLIN004||Phase 1/2 study of CAN04 (a fully humanized monoclonal antibody against L1RAP) in combination with different chemotherapy regimens in patients with advanced solid tumors.||I|
|ANV419-001||ANV419 Single Agent (Parts A-C)
or Combination (Part D) First in Human Study Phase 1/2: Open-label, Dose
Expansion Study in Patients with Relapsed/Refractory Advanced Solid Tumors.
|1463-0001||Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers.||I|
|INCB 106385-102||A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors.||I|
|GEIS-67 (SeliSarc)||Ensayo clínico aleatorizado fase I/II de selinexor más gemcitabina en determinados sarcomas de partes blandas y osteosarcomas avanzados.||I|
|M20-732||A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma.||I|
|AFM24-102||A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR expressing Cancers||I|
|TK-SCR-01||Assessing Frequency of HLA-Genotypes and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for T Cell Receptor Based Therapies.||EPA-OD|
|STRO-002-GM1||A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRα) Antibody Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers.||I|
|20140318 (MASTERKEY-318)||A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors Alone and in Combination with Systemic Pembrolizumab (MASTERKEY-318).||I|
|1403-0001||A phase Ia/Ib, open labeA phase
Ia/Ib, open label, multicenter, dose-escalation study of
BI 907828 in patients with advanced or metastatic solid tumorsl, multicenter, dose-escalation stud
|D9720C00001(PETRA)||A Modular Phase I/IIa, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5305 monotherapy and in combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies.||II|
|D967LC00001(DESTINY 3)||A Phase 1b/2 Multicenter,
Open-label, Dose-escalation and Doseexpansion Study to Evaluate the Safety,
Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and
Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer (DESTINY-Gastric03).
Francesc Bosch is Principal Investigator of VHIO’s Experimental Hematology Group, Professor of Hematology and Head of the Department of Hematology of the Vall d’Hebron University Hospital (HUVH), Barcelona.
He graduated from the Universitat de Barcelona (UAB) Medical School in 1988, and from 1989 – 1992 he carried out his training as a Resident in hematology at the Hospital Clínic in Barcelona. In 1997 Francesc was awarded his PhD by the UAB for his research centering on the over-expression of Cyclin D1 in chronic lymphoproliferative disorders under the supervision of Elias Campo. He subsequently carried out a two-year postdoctoral stay in the laboratory of Riccardo Dalla-Favera at the Institute of Cancer Genetics, Columbia University, New York (USA).
He then returned to the Hospital Clínic in the year 2000 where he continued to study CLL, and was later appointed as Head of the Department of Hematology and Director of the Experimental Hematology Laboratory at the Vall d´Hebron University Hospital in September 2009. He conducts both clinical and basic research in CLL and other lymphoproliferative disorders, with particular focus on the molecular pathogenesis of CLL and the development of novel therapeutic approaches.
Since 1995 he has been involved in the development of clinical trials in CLL and has made seminal contributions in the prognosis, assessment and treatment of CLL. He is also Chair of the Spanish CLL Working Group (GELLC) which leads the development of CLL clinical trials across Spain. Francesc has published over 100 papers in several peer-reviewed journals including those with the highest-impact factors such as The New England Journal of Medicine, Nature Medicine, Cancer Cell, Blood, Journal of Clinical Oncology, and Leukemia. In addition, he has authored or co-authored several Reviews and Book Chapters on CLL and other lymphoproliferative disorders.
VHIO’s Experimental Hematology Group conducts translational, pre-clinical and clinical research on hematological neoplasms of both lymphoid and myeloid origin. Our research team comprises hematologists and biological scientists who work closely together to design, conduct and lead our research programs.
We aim to address unmet clinical needs identified by hematologists, with the ultimate goal of translating our results to patients by developing early phase clinical trials and defining novel biomarkers to improve diagnosis, prognosis and treatment outcomes.
We seek to provide new therapeutic options for our patients by deciphering the mechanisms implicated in the pathogenesis and progression of hematological malignancies. Our investigators conduct preclinical studies of new therapeutic approaches for patients diagnosed with hematological malignancies. We identify novel biomarkers in hematology that will lead to a more rational and precise diagnosis, prognosis and treatment of patients.
The Hematology Clinical Trials Unit is currently participating in more than 140 recruiting clinical studies, including phase I clinical trials (n=49) and first-in- human studies of targeted therapies, both in lymphoid and myeloid malignancies. Last year 182 patients were included in our clinical studies, with 83 patients enrolled in phase I trials.
|Trial No.||Clinical Trial||Phase|
|CC-220-MM-001||A PHASE 1B/2A MULTICENTER, OPEN-LABEL, DOSEESCALATION STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE, ASSESS THE SAFETY AND TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-220 MONOTHERAPY AND IN COMBINATION WITH DEXAMETHASONE IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA||I|
|PCYC-1141-CA (PERSPECTIVE)||A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma||III|
|X16082||Ensayo de fase Ib/II para evaluar la eficacia y seguridad de ixazomib oral en combinación con sirólimus y tacrólimus como profilaxis de la enfermedad injerto contra huésped crónica.||I|
|NP30179||A MULTICENTER, OPEN-LABEL, PHASE I STUDYTO EVALUATE THE SAFETY, EFFICACY, TOLERABILITY AND PHARMACOKINETICS OF ESCALATING DOSES OF RO7082859 AS A SINGLE AGENT AND IN COMBINATION WITH OBINUTUZUMAB ADMINISTERED AFTER A FIXED, SINGLE DOSE PRE-TREATMENT OF OBINUTUZUMAB (GAZYVA/GAZYVARO) IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA||I|
|SHP620-302 (AURORA)||A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients||III|
|NP39488||AN OPEN-LABEL, MULTI-CENTER, PHASE IB STUDY OF RO7082859 AND ATEZOLIZUMAB (PLUS A SINGLE PRE-TREATMENT DOSE OF OBINUTUZUMAB) IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA||I|
|JCAR017-BCM-001||Ensayo de fase II, multicéntrico, de cohortes múltiples y de un solo brazo para evaluar la eficacia y seguridad de JCAR017 en sujetos adultos con linfoma no Hodgkin de células B agresivo||II|
|UTX-TGR-205||A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma||II|
|GO29781||An open-label, multicenter, phase I/Ib trial evaluating the safety and pharmacokinetics of escalating doses of BTCT4465A as a single agent and combined with atezolizumab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia||I|
|2102-HEM-101||A Phase 1/2, Multicenter, Open-label study of FT 2102 as a single agent and in combination with Azacitidine or Cytarabine in patiens with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation||II|
|DU176b-A-U157||A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NONRANDOMIZED STUDY TO EVALUATE PHARMACOKINETICS AND PHARMACODYNAMICS OF EDOXABAN IN PEDIATRIC PATIENTS||I|
|63709178AML1001||A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects with Relapsed or Refractory AML.||I|
|AG120-C-009||A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation||III|
|B0661037||A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS HROMBOEMBOLIC EVENT||III|
|NP40126||A PHASE 1B STUDY EVALUATING RO7082859 IN COMBINATION WITH RITUXIMAB (R) OR OBINUTUZUMAB (G) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN PARTICIPANTS WITH RELAPSED REFRACTORY FOLLICULAR LYMPHOMA (R/R FL) OR IN PARTICIPANTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA||I|
|R1979-ONC-1504||A PHASE 1 STUDY TO ASSESS SAFETY AND TOLERABILITY OF REGN1979, AN ANTI-CD20 X ANTI-CD3 BISPECIFIC MONOCLONAL ANTIBODY, AND REGN2810, AN ANTI-PROGRAMMED DEATH-1 MONOCLONAL ANTIBODY, IN PATIENTS WITH B-CELL MALIGNANCIES||I|
|PCI-32765CAN3001||A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study.||III|
|ARMY-1||First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia||I|
|DU176b-D-U312||A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)||III|
|63935937MDS3001 (Imeteslstat)||A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment||III|
|17-BI-1206-02||Ensayo clínico de fase I/IIa de BI-1206, un anticuerpo monoclonal contra CD32b (Fc γ RIIB), en combinación con rituximab en personas con linfoma no hodgkiniano de linfocitos B de escasa malignidad que ha recidivado o es resistente al rituximab||I|
|Ponatinib-3001||Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (Ph+ ALL)||III|
|CL02-ORY-1001AML (ALICE)||A pilot study to assess the safety, tolerability, dose finding and efficacy of ORY-1001 in combination with azacitidine in older patients with AML in first line therapy.||II|
|207497-II (DREAMM6)||A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma – (DREAMM 6)||II|
|GO40554||A PHASE I/II TRIAL OF MOSUNETUZUMAB (BTCT4465A) AS CONSOLIDATION THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA FOLLOWING FIRST-LINE IMMUNOCHEMOTHERAPY AND AS THERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA WHO ARE UNABLE TO TOLERATE FULL-DOSE CHEMOTHERAPY.||I|
|CC-99282-NHL-001||A PHASE I, MULTI-CENTER, OPEN-LABEL STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF AN ORALLY AVAILABLE SMALL MOLECULE, CC-99282, ALONE AND IN COMBINATION WITH RITUXIMAB IN SUBJECTS WITH RELAPSED OR REFRACTORY NONHODGKIN LYMPHOMAS (R/R NHL)||I|
|GEM2017FIT||Tratamiento de inducción con bortezomib, melfalán y prednisona (VMP) seguido de lenalidomida y dexametasona (Rd) frente a carfilzomib, lenalidomida y dexametasona (KRd) más/menos daratumumab, 18 ciclos, seguido de tratamiento de consolidación y mantenimiento con lenalidomida y daratumumab: un ensayo clínico de fase III, multicéntrico, aleatorizado para pacientes adultos mayores, de entre 65 y 80 años, con buen estado general y mieloma múltiple de nuevo diagnóstico.||III|
|BGB-3111-305||A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.||III|
|ACE-CL-311/D8221C00001||Ensayo fase 3, aleatorizado, multicéntrico y abierto para comparar la eficacia y seguridad de acalabrutinib (ACP-196) en combinación con venetoclax con y sin obinutuzumab, con la eficacia y seguridad de la quimioinmunoterapia elegida por el investigador en pacientes con leucemia linfocítica crónica sin mutación del(17p) o TP53 no tratada previamente”||III|
|2018-523-00US1||A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients with Relapsed or Refractory Lymphoma.||I|
|PonaZero||Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Effect of a One-Year Consolidation Treatment with Ponatinib 15 mg on Treatment Free-Remission Rate in Patients with Philadelphia-Positive Chronic Myeloid Leukemia, who had previously Achieved a Deep Molecular Response with Imatinib.||II|
|MOM-M254-001||A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura||II|
|GC-LTFU-001||Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells||II|
|ME-401-003||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies||II|
|67856633LYM1001||A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL||I|
|MT-3724_NHL_001||Safety, Pharmacodynamics and Efficacy of MT- 3724 for the Treatment of Patients with Relapsed or Refractory DLBCL||II|
|ATA129-EBV-302 (TABELECLEUCEL)||Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study).||III|
|BST-LT-01||Ensayo clínico fase Ib-II, prospectivo, multicéntrico, abierto y no controlado para evaluar la seguridad y eficacia inmunológica de la infusión de linfocitos T específicos frente a virus a partir del mejor donante disponible en receptores de un trasplante alogénico de progenitores hematopoyéticos||II|
|B1931030||A PHASE 4, OPEN-LABEL, RANDOMIZED STUDY OF TWO INOTUZUMAB OZOGAMICIN DOSE LEVELS IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA ELIGIBLE FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION AND WHO HAVE RISK FACTOR(S) FOR VENO-OCCLUSIVE DISEASE.||III|
|CSEG101A2301||“Estudio de fase III, multicéntrico, aleatorizado y doble ciego para evaluar la eficacia y seguridad de dos dosis de crizanlizumab frente a placebo, con o sin hidroxiurea/hidroxicarbamida, en pacientes adolescentes y adultos con enfermedad de células falciformes con crisis vaso-oclusivas (STAND)”||III|
|BP41072||AN OPEN-LABEL, PHASE I STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF RO7227166 (A CD19 TARGETED 4-1BB LIGAND) IN COMBINATION WITH BINUTUZUMAB AND IN COMBINATION WITH RO7082859 (CD20-TCB) FOLLOWING A PRE-TREATMENT DOSE OF OBINUTUZUMAB ADMINISTERED IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA.||I|
|R1979-ONC-1625||“AN OPEN-LABEL STUDY TO ASSESS THE ANTI-TUMOR ACTIVITY AND SAFETY OF REGN1979, AN ANTI-CD20 X ANTI-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA”||II|
|ADCT-301-201||“A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma”||II|
|DREAMM 7 (GSK 207503)||DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of ratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma.||III|
|207499 (DREAMM 8)||A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8).||III|
|AFM13-202 (REDIRECT)||A phase II Open label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients with relapsed or refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REIDRECT)||II|
|CLR_15_03||“A Two-part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)”||II|
|C0371004||AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF FACTOR IX (FIX) PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C£2%) WHO ARE NEGATIVE FOR NEUTRALIZING ANTIBODIES (NAB) TO ADENO-ASSOCIATED VIRUS VECTOR (AAV)-SPARK100”||III|
|B7841005 (PXL 241325)||“An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis”||III|
|AML003/(UYA26495)||Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥ 60 years). with Relapsed/Refractory Acute Myeloid Leukemia (AML)||III|
|CCTL019A2205B||Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CAR T-Cell Therapy.||II|
|QUIWI||A 2:1 randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type AML||II|
|KRT-232-104||"An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)"||I|
|ACE-536-MDS-002||A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects who require Red Blood Cell Transfusions.||III|
|Pevonedistat-1016||“A Phase 1/1b Study of Pevonedistat in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myelogenous Leukemia With Severe Renal Impairment or Mild Hepatic Impairment”||I|
|CCTL019H2301 (BELINDA)||Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)||III|
|INCB01158-206-II||A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma||II|
|CSEG101A2203||A Phase II, multicenter, randomized, open label two arm study comparing the effect of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy (STEADFAST).||II|
|ACE-536-LTFU-001||A PHASE 3B, OPEN-LABEL, SINGLE-ARM, ROLLOVER STUDY TO EVALUATE LONG-TERM SAFETY IN SUBJECTS WHO HAVE PARTICIPATED IN OTHER LUSPATERCEPT (ACE-536) CLINICAL TRIALS.||III|
|C935788-057||A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia||III|
|CC-220-MM-001-II||A PHASE 1B/2A MULTICENTER, OPEN-LABEL, DOSE ESCALATION STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE, ASSESS THE SAFETY AND TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-220 MONOTHERAPY AND IN COMBINATION WITH DEXAMETHASONE IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA||II|
|64619178EDI1001-H||A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects with Advanced Cancers.||I|
|GLLC-EARLY||Phase III Randomized Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Early Stage CLL With High Risk of Disease Progression (GELLC-8).||III|
|53718678RSV2005 (FREESIA)||A randomized, double blind, placebo-controlled study to evaluate the clinical outcomes, antiviral activity, safety, tolerability, pharmacocinetics, and pharmacocinetics/pharmacodynamics of JNJ-53718678 in adult and adolescent hematopoietic stem cell transplant recipients with respiratory syncytial virus infection of the upper respiratory tract.||II|
|CMBG453B12301||A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2).||III|
|CMBG453E12101||A Phase Ib, multicenter, open-label study of MBG453 and canakinumab or NIS793 in adult patients with lower risk myelodysplastic syndrome||I|
|ARGX-113-1801||“A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia”||III|
|AB15003||A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety of oral masitinib to placebo un treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment.||III|
|ASPER-III-19-1||A Phase 3, Double-Blind, Multicentric, Randomised, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability ofltraconazole Dry Powder for Inhalation for the Prevention of Invasive Mould Disease in Patients with Acute Leukaemia and Neutropaenia.||III|
|BGB-3111-306||“A Phase 3 Randomized, Open-Label, Multicenter Study comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma who are ineligible for Stem Cell Transplantation”||III|
|67571244AML1001||A Phase 1, First-in-Human, Dose Escalation Study of JNJ-67571244 (bispecific antibody targeting CD33 and CD3) in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).||I|
|AUTO4-TL1||A SINGLE ARM, OPEN-LABEL, MULTI-CENTRE, PHASE I/II STUDY EVALUATING THE SAFETY AND CLINICAL ACTIVITY OF AUTO4, A CAR T CELL TREATMENT TARGETING TRBC1, IN PATIENTS WITH RELAPSED OR REFRACTORY TRBC1 POSITIVE SELECTED T CELL NON-HODGKIN LYMPHOMA.||I|
|CO41685||A PROSPECTIVE, OPEN-LABEL, MULTICENTER RANDOMIZED PHASE III STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINED REGIMEN OF VENETOCLAX AND OBINUTUZUMAB VERSUS FLUDARABINE, CYCLOPHOSPHAMIDE, AND RITUXIMAB (FCR)/ BENDAMUSTINE AND RITUXIMAB (BR) IN FIT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITHOUT DEL(17P) OR TP53 MUTATION||III|
|RVT-1401-2003||A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia.||II|
|CC-99282-CLL-001||A PHASE 1B, MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-99282 IN COMBINATION WITH OBINUTUZUMAB IN SUBJECTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA.||I|
|CJBH492A12101||A phase I/Ib open-label, multi-center dose escalation study of JBH492 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL).||I|
|ACE-LY-312 (D8227C00001)||A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma||III|
|GCT3009-01||“Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A Firstin-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts”||I|
|GCT3013-01||A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma||I|
|CO41942||ESTUDIO DE FASE IB, SIN ENMASCARAMIENTO, MULTICÉNTRICO, NO ALEATORIZADO, PARA EVALUAR LA SEGURIDAD, LA FARMACOCINÉTICA Y LA EFICACIA DE MOSUNETUZUMAB EN COMBINACIÓN CON LENALIDOMIDA, O RO7082859 EN COMBINACIÓN CON LENALIDOMIDA, O RO7082859 EN COMBINACIÓN CON OBINUTUZUMAB MÁS LENALIDOMIDA EN PACIENTES CON LINFOMA FOLICULAR RESISTENTE O RECIDIVANT||I|
|ATA129-EBV-205||An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases||I|
|C3731003||Phase 3, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of PF 07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≤1%)||III|
|M13-494||A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14) Positive Relapsed or Refractory Multiple Myeloma||III|
|BAY 94-9027/19764 (JIVI)||Post marketing investigation (PMI) to assess safety and efficacy of JIVI (BAY 94-9027) treatment in patients with hemophilia A||III|
|FGCL-4592-082||Phase III trial, investigating efficacy and safety of roxadustat vs. placebo for treatment of anemia with low transfusion burden in patients with low risk MDS||III|
|CLL17||A phase 3 multicenter, randomized, prospective, open-label trial of ibrutinib monotherapy versus fixed-duration venetoclax plus obinutuzumab versus fixed-duration ibrutinib plus venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL)||III|
|BO42161||“A Phase III, Randomized, Open Label, Active-Controlled, multicenter study evaluating the efficacy and safety of Crovalimab vs Eculizumab in Adult and Adolescent patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently treated with compliment inhibitors”||III|
|SRA-MMB-301||A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy||II|
|MAA-304 (CRIMSON 1)||Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On demand reatment and Control of Bleeding Episodes in Subjects with Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study.||III|
|WP42004||"ESTUDIO DE FASE I, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA SEGURIDAD, TOLERABILIDAD, FARMACOCINÉTICA Y FARMACODINÁMICA DE RO7283420 EN MONOTERAPIA EN LEUCEMIA MIELOIDE AGUDA EN RECAÍDA/RESISTENTE HEMATOLÓGICA Y MOLECULAR"||I|
|CAEL-101-301||“A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis”||III|
|CAEL-101-302||“A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis”||III|
|ALXN-1210-TMA-313||Estudio de fase III, abierto, aleatorizado y multicéntrico de ravulizumab en pacientes adultos y adolescentes que presentan microangiopatía trombótica (MAT) después de un trasplante de células madre hematopoyéticas (TCMH).||III|
|M15-954||A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS).||III|
|74856665AML1001||A Phase 1, First-in-Human, Dose Escalation Study of JNJ-74856665 (DHODH inhibitor) in Participants with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome||I|
|XPORT-DLBCL-030||“A PHASE 2/3, MULTICENTER RANDOMIZED STUDY OF RITUXIMAB-GEMCITABINEDEXAMETHASONE- PLATINUM (R-GDP) WITH OR WITHOUT SELINEXOR IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (RR DLBCL)”.||II|
|MOR208C310||“A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, highintermediate and high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL)”||III|
|75348780LYM1001||“Ensayo fase 1, de primera administración en humanos, de escalado de dosis de JNJ-75348780, un anticuerpo biespecífico anti CD3xCD22, en sujetos con linfoma no Hodking (LNH) y leucemia linfocítica crónica (LLC).”||I|
|ZN-d5-001||“Phase 1 First in Human Dose Escalation Study of ZN d5 as a Single Agent in Subjects with Non-Hodgkin Lymphoma or Acute Myeloid Leukemia”||I|
|M16-109||A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis||II|
|KRT-232-109||An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib||I|
|GO41944||“ESTUDIO DE FASE III, ABIERTO, MULTICÉNTRICO Y ALEATORIZADO PARAEVALUAR LA EFICACIA Y LA SEGURIDAD DE GLOFITAMAB COMBINADO CONGEMCITABINA MÁS OXALIPLATINO EN COMPARACIÓN CON RITUXIMABCOMBINADO CON GEMCITABINA Y OXALIPLATINO EN PACIENTES CONLINFOMA DIFUSO DE CÉLULAS B GRANDES EN RECAÍDA/RESISTENTE AVANZADO IRRESECABLE”||III|
|AUTO1-AL1||“AN OPEN-LABEL, MULTI-CENTRE, PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF AUTO1, A CAR T CELL TREATMENT TARGETING CD19, IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY B CELL ACUTE LYMPHOBLASTIC LEUKAEMIA”||II|
|CYTB323A12101||Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL.||I|
|64264681LYM1002||A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia||I|
|CL1-64315-004||Estudio de fase I/II, internacional, multicéntrico, abierto, no aleatorizado y no comparativo de S64315, un inhibidor Mcl-1 administrado de forma intravenosa, en combinación con azacitidina, en pacientes con Leucemia Mieloide Aguda||I|
|CCTL019C2202 (BIANCA)||Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL) (BIANCA).||II|
|BO42203||A PHASE 1B STUDY EVALUATING THE SAFETY, EFFICACY AND PHARMACOKINETICS OF VENETOCLAX IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB (R) AND CYCLOPHOSPHAMIDE, DOXORUBICIN, PREDNISOLONE (CHP) IN PATIENTS WITH UNTREATED BCL−2 IMMUNOHISTOCHEMISTRY (IHC)-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)||I|
|ADCT-402-103||A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma||II|
|SGN35-031||A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)||III|
|GCT3013-02||A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody® -CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma||I|
|GCT3013-05||A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma||III|
|MK-1026-003||A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies.||I|
|EONHL1-20||A global multicenter phaSe 1/2 trial of EO2463, a novel microbial-derived peptIde therapeutic vaccine, as monotherapy, and in combination with lenaliDomide and rituximab, for treatmeNt of patients with indolEnt Non-Hodgkin's LYmphoma (the "SIDNEY" study).||I|
|4202-HEM-301||Estudio multicéntrico, aleatorizado, controlado con placebo, doble ciego y adaptativo de FT-4202 oral, un activador de la piruvato cinasa en pacientes con anemia drepanocítica4202||II|
|ALXN2040-PNH-301||“A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)”.||III|
|AG348-C-017/ENERGIZE||A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non–Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)||III|
|AG348-C-018 (ENERGIZE-T)||A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T)||III|
|BGB-11417-101||A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies||I|
|SGN35-027||Multiple Part Clinical Trial of Brentuximab Vedotin in classical Hodgkin Lymphoma Subjects.||II|
|KRT-232-113||An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 with TL-895 in Subjects with Relapsed/Refractory Myelofibrosis and of KRT-232 in Janus-associated Kinase Inhibitor-Intolerant Myelofibrosis||I|
|INCB 50465-313||“A Phase 3, A Randomized, Double-blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants with Myelofibrosis”||III|
|INCB 50465-304||A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib||III|
|64407564MMY1001||A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma||II|
|KTE-C19-102 (ZUMA-2)||A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2).||II|
|2020-306-GLOB1||“A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations”||I|
|DS3201-A-U202||Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma (Valemetostat tosylate [DS-3201b], an enhancer of zeste homolog [EZH] 1/2 dual inhibitor, for R/R PTCL)||II|
|SNDX-6352-0504||A Phase 2, Openlabel, Randomized, Milticenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses who have Recived at least 2 Lines of Systemic Therapy.||II|
|KRT-232-117||“An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with a Tyrosine Kinase Inhibitor (TKI) in Patients with Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)”||I|
|TL-895-203||An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with KRT-232 in Subjects with Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML).||I|
|ENHANCE (5F9009)||“ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome.”||III|
|CMBG453F12201||“Estudio de fase Ib/II abierto de sabatolimab como tratamiento para pacientes con leucemia mieloide aguda y enfermedad residual medible después de un trasplante alogénico de células madre”||I|
|INCMOR0208-101||A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Combination Therapy with the anti-CD19 Monoclonal Antibody Tafasitamab and the PI3Kd Inhibitor Parsaclisib in Adult Participants with Relapsed/Refractory Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia.||I|
|NN7415-4311 (EXPLORER7)||Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors.||III|
|54767414ALL2005 (DELPHINUS)||A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma||II|
|HOVON-156 AML/ AMLSG 28-18||“Estudio de fase 3 multicéntrico, abierto y aleatorizado de gilteritinib frente a midostaurina, en combinación con un tratamiento de inducción y consolidación, y seguido de un tratamiento de mantenimiento, en pacientes aptos para someterse a una quimioterapia intensiva a los que se les ha diagnosticado recientemente leucemia mielógena aguda (LMA) osíndromes mielodisplásicos con exceso de blastos tipo 2 (SMD EB2) y mutaciones del gen FLT3 ”||III|
|HOVON 150 AML / AMLSG 29-18||A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy||III|
|D8230C00002||A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations with Anti-cancer Agents in Patients with Advanced Haematological Malignancies||I|
|KRT-232-101||A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT-232 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment||III|
|68284528MMY3004 (CARTITUDE-5)||A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.||III|
|BO42452||A PHASE IB RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB FOR THE MANAGEMENT OF ACUTE UNCOMPLICATED VASO-OCCLUSIVE EPISODES (VOE) IN PATIENTS WITH SICKLE CELL DISEASE (SCD).||I|
|75276617ALE1001||A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants with Acute Leukemia.||I|
|GLA 2017-R2 (Pola-R-ICE)||Estudio fase III abierto, prospectivo, para comparar polatuzumab vedotin más rituximab, ifosfamida, carboplatino y etopósido (Pola-R-ICE) y rituximab, ifosfamida, carboplatino y etopósido (R-ICE) solo como terapia de rescate en pacientes con linfoma difuso de célula B grande (LDCBG) primariamente refractarios o en recaída||III|
|BO43243||A PHASE IB OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF MOSUNETUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA.||I|
|M16-191 (TRANSFORM-1)||A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis.||III|
|C1071005||An Open-Label, 3-Arm, Multicenter, Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab vs Daratumumab + Pomalidomide + Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma.||III|
|Trial No.||Clinical Trial||Phase|
|FMS-ITK-2016-01||Estudio observacional prospectivo para evaluar la precocidad, estabilidad y profundidad de la respuesta molecular en pacientes recién diagnosticados de leucemia mieloide crónica en fase crónica (LMC-FC) tratados con inhibidores de la actividad tirosina-quinasa (ITK) como tratamiento de primera línea en la práctica clínica||IV|
|GEM-MIE-2014-01||Estudio observacional prospectivo para identificar los aspectos clínicos que conducen a la toma de decisiones terapéuticas en pacientes con mielofibrosis.||IV|
|AG348-C008||Pyruvate Kinase Deficiency Global Longitudinal Registry||IV|
|MSD-CMV-2017-01||ESTUDIO SOBRE LAS COMPLICACIONES CLÍNICAS DIRECTAS E INDIRECTAS DERIVADAS DE LA DETECCIÓN DE LA INFECCIÓN POR CITOMEGALOVIRUS (CMV) EN PACIENTES CON TRASPLANTE ALOGÉNICO DE CÉLULAS PROGENITORAS HEMATOPOYÉTICAS (ALO-TPH). ESTUDIO CMV-ALOTPH||IV|
|CEL-MIE-2016-01||Estudio observacional para valorar la carga de la enfermedad, en términos de Calidad de Vida Relacionada con la Salud y costes sanitarios directos, en pacientes con Mieloma Múltiple de nuevo diagnóstico no candidatos a trasplante autólogo de progenitores hematopoyéticos en España Estudio QoLMMBuS.||IV|
|CC-5013-MDS-010 (216900) (Kaleidoscope)||A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide||IV|
|AIE-ART-2016-01 (vertex 2.0)||Estudio retrospectivo para evaluar el uso de agonistas de los receptores de trombopoyetina en pacientes adultos con trombocitopenia inmune primaria en España||IV|
|CEL-MIE-2012-01||Estudio observacional post-autorización para evaluar la respuesta de la función renal al tratamiento de pacients con mieloma múltiple en recaída y con aclaramiento de creatinina||IV|
|GCP#04.01.020/030 (Nicord Seguiment)||Long Term Follow Up for Patients who have received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells||IV|
|BAX-OCT-2011-01/061001 (AHEAD)||ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM).||IV|
|GENA-25||Uso práctico de concetrados FVIII de Octafarma en paciente con hemofilia A sin tratamiento previo o mínimamente tratados que se incorporan a un tratamiento clínico rutinario: estudio observacional de la seguridad y eficacia en un entorno real: "Protect Now"||IV|
|JAN-DAR-2018-01||Estudio observacional para describir el impacto de las combinaciones de tratamiento con daratumumab frente a otros tratamientos alternativos en pacientes con mieloma múltiple en recaída / refractario (MMRR). Datos de práctica clínica habitual en España. Estudio GeminiS.||IV|
|INS-FAN-2017-01 (IG1403)||A post authorization study to asses the safety and efficacy of Fandhi (Double inactivated human anti-hemophilic factor) sin subjects with Von Willebrand disease.||IV|
|GEM-DAR-2018-01||Treatment with Daratumumab in relapsed / refractory Multiple Myeloma patients in clinical care practice in Catalonia. A retrospective study||IV|
|ATA129-RS002||A Retrospective Study of Treatment Outcomes in Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disorder after Hematopoietic Cell Transplant or Solid Organ Transplant who have Failed Rituximab or Rituximab Plus Chemotherapy.||IV|
|DNO-IBR-2018-01||Virología e inmunología de la infección por el citomegalovirus (CMV) en el paciente con neoplasias hematológicas en la era de las nuevas bioterapias.||IV|
|Sobi.Elocta-005 (A-MORE)||Estudio observacional, multicéntrico de 48 meses de seguimiento para evaluar la eficacia a largo plazo de Elocta en la salud articular.||IV|
|C-935788-058||A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia||IV|
|54767414MMY4024 / JAN-DAR-2019-02||Estudio observacional para describir la repercusión de los anticuerpos monoclonales como tratamiento de primera línea frente a otros regímenes estándar en pacientes con mieloma múltiple de nuevo diagnóstico que no sean candidatos a trasplante. Datos de práctica clínica habitual en España.||IV|
|CEL-BEN-2019-01 (MYHRAI)||Real-world trends in clinical management of Relapsed/Refractory Multiple Myeloma (RRMM) patients who have received at least 2 prior anti-myeloma regimens: results from exploring electronic health records (EHR) with artificial intelligence (AI) – ‘’MYHRAI study’’||IV|
|KTE-iNHL-RW2020||Real-World Response/Survival and Treatment Patterns among Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in USA, UK, France, and Spain Oncology Practices.||IV|
|ML40944 (HEMOLIFE)||ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA CALIDAD DE VIDA DE PACIENTES CON HEMOFILIA A SIN INHIBIDORES.||IV|
|TAK620-5002||“Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study (OTUS) following hematopoietic Stem Cell Transplant (HSCT)”.||IV|
|BAY-DAM-2019-01 (HEM-POWR)||HEM-POWR: Estudio observacional para evaluar la eficacia y la seguridad del tratamiento con damoctocog alfa pegol en la vida real en pacientes con hemofilia A tratados previamente.||IV|
|MOTIVATE||“MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial”||IV|
|TAK-660-403||Evaluation of long-term safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, rurioctocog alfa pegol) in patients with haemophilia A – An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS).||IV|
|TAK-705-3003||Natural History and Treatment Outcomes of Congenital and Immune Thrombotic Thrombocytopenic Purpura: a Retrospective Chart Review Study||IV|
|Sobi.Alprolix-002 (B-MORE)||Estudio observacional y multicéntrico de 48 meses para evaluar la eficacia a largo plazo de Elocta en la salud articular.||IV|
Areas of Research
Prizes and Scholarships
VHIO’s Gastrointestinal & Endocrine Tumors Group continues to play an essential role in developing molecular therapies against GI malignancies. We pioneer transformative research of excellence and lead the development of new anti-cancer agents in early-phase clinical trials to generate novel biomarkers and targets that accelerate the delivery of precision oncology to our patients.
In 2021, our group played a central role in several clinical trials evaluating the efficacy of immunotherapy and targeted agents in GI tumors. Among these, we co-authored a manuscript describing the interim results of the phase III KEYNOTE-811 showing the benefit of standard-of-care trastuzumab and chemotherapy plus anti-PD-1 in patients with advanced-stage HER2+ gastric cancer. Importantly, amidst the COVID-19 pandemic, we have led and participated in several studies evaluating the impact of SARS-CoV2 infection in therapy response, outcomes and long-term effects of the disease in cancer patients, and contributed to generating guidelines to minimize the impact of the pandemic in patient care.
We have also made significant progress in validating and developing non-invasive liquid biopsy technologies and biomarkers to enable a more precise monitoring of cancer patients. Moreover, our research keeps providing evidence that molecular profiling of patients is an effective approach to guide the selection of GI cancer patients for targeted treatments that result in improved outcomes.
Our multidisciplinary team integrates medical oncologists and clinical investigators, a translational researcher with expertise in biomarker discovery, a research nurse dedicated to monitoring patients in research programs, laboratory technicians specialized in molecular biology and patient-derived xenografts (PDX), data curators, as well as other professionals involved in the study of precision medicine against GI malignancies. We also work in close collaboration with other VHIO researchers and groups through our highly interactive and functional Taskforces in colorectal and pancreatic cancers.
Joan Carles received his MD degree in Medicine and Surgery in 1987 from the Universidad de Barcelona (UAB), from where he later obtained his PhD in 1992. He completed his specialty training in Medical Oncology at the Hospital Universitario Germans Trias i Pujol in Badalona (Barcelona), and in 1996 received the European Certificate in Medical Oncology in Wien.
In 1991 he joined the Medical Oncology Unit at the Hospital de Terrassa and from April 1992 to September 2008, he was a Medical Oncologist at the Hospital del Mar, Barcelona. Joan joined the Medical Oncology Department at the Vall d’Hebron University Hospital (HUVH) in September 2008, and currently serves as Principal Investigator of VHIO’s Genitourinary, CNS Tumors, Sarcoma & Cancer of Unknown Primary Site Group.
He is Co-Founder of the Spanish Society for the Treatment of Genitourinary Cancer (SOGUG), for which he was appointed as Secretary and Vice-President in 1999 and 2012 respectively. He is also member of the Spanish Sarcoma Research Group (GEIS). Since 1995, he has continued to serve as part-time Professor of Medicine at the Universidad Autónoma de Barcelona where he is also Coordinator of the Medical Oncology training program.
He has authored more than 148 articles and delivered more than 398 presentations at congresses and meetings of excellence. He is also Author of several book chapters.
Joan’s research interests surround clinical genitourinary oncology, sarcoma and early and translational clinical research in angiogenesis as well as immunotherapy and targets in cancer therapy. He also coordinates multicenter as well as national clinical trials for new drugs aimed against prostate, kidney and bladder cancers.
In addition, he is Member of the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), and the Spanish Association of Medical Oncology (SEOM). He acts as a consultant in an advisory capacity for the preparation and development of oncology guidelines for the government of Catalunya (Oncoguies Catsalut). He has also been appointed as consultant for national oncology grants from Spain, Italy, Switzerland, Ireland, France and Finland.
We are dedicated to advancing clinical and translational research against cancer, with extensive experience and expertise in treating various neoplasms. In collaboration with urologists and radiation therapists we design and develop clinical trials for genitourinary malignancies at different stages of disease.
In 2021 we continued to consolidate our expert Prostate Cancer Task Force. By closely connecting clinical and translational researchers at VHIO and the Vall d’Hebron Research Institute (VHIR), we have initiated various translational prostate cancer projects. We are also pursuing translational studies in kidney cancer, working with other partners including the Biomedical Research Institute of Bellvitge (IDIBELL, Barcelona).
Over recent years, several advances have led to the more effective treatment of GU malignancies. Immunotherapy (IO) is proving increasingly important against bladder and kidney cancers. Concerning the latter, immune-based therapies in combination with others, or paired with antiangiogenics, are considered the new standard of care in first-line therapy. We are studying new combinations including HIF-2 alpha inhibitors and immunomodulators.
In bladder cancer, immunotherapy has shown activity in metastatic disease and is now being tested in the neoadjuvant setting and in non-muscle-invasive bladder cancer. It has recently been shown that immunotherapy as maintenance therapy after 4/6 cycles of chemotherapy in first-line treatment improves progression-free survival (PFS) and overall survival (OS). Molecular alterations have been identified in bladder cancer such as FGFR mutations. The unmasking of molecular alterations enables us to develop new targeted drugs. Also under development are antibody-drug conjugates (ADCs) for the treatment of patients with metastatic disease.
Our group, and others, have observed that immunotherapy could also be effective in certain subgroups of patients with castration-resistant prostate cancer. We are currently participating in phase I studies to assess immune-based cancer medicines for the treatment of this patient population. Another innovative treatment for prostate cancer is theragnosis by administering radioligands using beta emitters. This type of therapy requires close collaboration with nuclear medicine teams to coordinate the administration and follow-up of patients.
We have participated in recent studies that have shown the utility of immune checkpoint inhibitors (ICIs) in the adjuvant treatment of bladder and kidney cancers with a high risk of disease recurrence. These studies can only be performed by working closely with our Vall d’Hebron University Hospital’s (HUVH) Urology Department.
We also collaborate with various other renowned research centers including the Cleveland Clinic (Ohio, USA), University of California, San Francisco (California, USA), and participate in studies carried out in partnership with the Gustave Roussy Institute (Paris, France), Barts Health NHS Trust – Hospital (London, UK), and Kantonsspital St. Gallen (Switzerland). This year we have continued to expand our translational research program in prostate cancer working alongside VHIO’s Prostate Cancer Translational Research Group, led by Principal Investigator Joaquin Mateo, as well as other hospitals in Catalonia.
Our main focus is metastatic castration-resistant prostate cancer (mCRPC), and we are working on a project led by Joaquin Mateo, entitled Clinical Qualification of DNA Repair Defects as Biomarkers in Metastatic Prostate Cancer Using Integrated Genomics and Tissue-Based Functional Assays. This research is supported by the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Program. Additionally, we are participating in the IRONMAN project directed by the Memorial Sloan Kettering Cancer Center (MSKCC – New York, USA), as the Spanish national repository for the IRONMAN registry. This international program aims at building a comprehensive bank of clinical data and biospecimens from metastatic prostate cancer patients.Our involvement in this project is supported by the Movember Foundation and Fundación FERO (FERO Foundation).
We are collaborating with VHIO’s Radiomics Group, headed by Raquel Perez-Lopez, to analyze MRI alterations in patients who have started hormonal treatments for metastatic prostate cancer, and correlate these data with bone biopsies, performed in parallel. This project, iPROMET: a study for clinical validation of whole- body diffusion-weighed MRI as a response biomarker of bone metastases in patients with prostate cancer, counts on the combined expertise of a urologist, radiation oncologist, radiologist, and a medical oncologist to establish a circuit for the systematic metastatic tissue acquisition from prostate cancer patients at Vall d’Hebron.
We have expanded our avatar program for kidney cancer tumors in collaboration with IDIBELL and implanted 35 tissue samples, 15 of which have grown. We were able to obtain data about treatment resistance in 8 cases. In organoids, we have sent 4 cases and 3 are growing. Additionally, we continue to participate in the REVOLUTION project, pREdiction of niVOLUmab acTION metastatic renal cancer patients: Treg function, tumoral access and NK interactions as predictive biomarkers of immunotherapy. This research is supported by TRANSCAN-2 ERA-NET, under the scope of the EU Framework Programme Horizon 2020.
In collaboration with other professionals in neurosurgery and radiation therapy, we lead and develop several multidisciplinary clinical studies and phase I trials in CNS tumors. Additionally, alongside VHIO’s Gene Expression & Cancer Group led by Joan Seoane, we continue to develop our translational research platform for glioblastoma. We analyze cfDNA in blood and cephaloraquidic liquid to assess primary CNS tumors and metastases.
Our group also participates in a project directed by the European Organisation for Research and Treatment of Cancer (EORTC, Brussels, Belgium), against several tumor types, working on CNS tumors: Screening Platform for Efficient Clinical Trial Access (SPECTA). The main objective is to screen patients and develop academic clinical trials based on molecular stratification. This initiative is supported by the European Cancer Research Fund (ECRF) and Walgreens Boots Alliance (WBA). We are also active at the national level in a medulloblastoma platform to better define and classify these cancers.
We continue to work closely with the Spanish Sarcoma Group (GEIS) on clinical trials at different stages of disease with emphasis on a histology-tailored design, and are currently setting up a translational platform for sarcomas and basic research in partnership with IDIBELL and the Cancer Research Center of Salamanca – CIC (Spain). In GIST tumors, we are working with Jonathan Fletcher’s lab at the Brigham and Women’s Hospital (Boston, USA).
We are now recognized as a Reference Unit of the Spanish National Health System (Centros, Servicios y Unidades de Referencia del Sistema Nacional de Salud - CSUR) for the treatment of sarcoma patients. This accreditation enables us to participate in the European Reference Network (ERN) for sarcoma tumors and other rare diseases.
Since César Serrano set up his own research team, VHIO’s Sarcoma Translational Research Group in 2019, we have consolidated different clinical trials with new drugs in GIST by leading and participating in phase I-II-III studies. Our Serum Bank now incorporates the majority of tumor types that we study (CNS tumors, GIST; renal cell carcinoma and CRPC), and we will continue to collect samples from our patients. Dedicated to promoting education and exchange, in 2021 we welcomed three fellows from Spain for 3-month short stays.
Ana Oaknin obtained her licensure in Medicine and Surgery from the Universidad Complutense de Madrid in 1994, specialized in Medical Oncology at the Hospital Universitario de la Princesa (Madrid, Spain), from April 1996 until April 2000, and obtained her Medical Degree – Doctor in Medicine and Surgery cum laude from the Universitat Autònoma de Barcelona (Barcelona, Spain).
She then completed her training by academic rotations at the Breast Oncology Medical Department, the University of Texas MD Anderson Cancer Center, Houston (Texas, USA), and later served as a Fellow at the Gynecological Oncology Department of the Memorial Sloan Kettering Cancer Center – MSKCC (NYC, USA), from 2003 -2004.
She has also worked at MD Anderson International in Madrid, 2000 - 2002, the Instituto Oncológico Teknon – Teknon Institute of Oncology (Barcelona), February 2002 – February 2006, Instituto Catalán de Oncología (ICO) – Catalan Institute of Oncology and the Hospital Duran y Reynals, Hospitalet (Barcelona), 2006 – 2008.
She is currently Principal Investigator of VHIO’s Gynecological Malignancies Group. She mainly focuses on clinical research and leads various phase I-II-III clinical studies at both the national and international levels. Her research centers on angiogenesis, immunotherapy and DNA repair mechanisms and she has also pioneered clinical trials with novel molecules that act on these molecular pathways that all assume crucial roles in the development and growth of gynecological tumors.
Ana is a distinguished member of ESMO, for which she serves as a Faculty Member of the Gynecological Tumors Track and a Subject Editor of its Guidelines Committee. She is also a member of several cooperative groups including GEICO (Spanish Group for Investigation on Ovarian Cancer), GOG (Gynecologic Oncology Group), GCIG (gynecologic Cancer InterGroup), as well as other leading scientific societies including the American Society of Clinical Oncology (ASCO), and the Spanish Society of Medical Oncology (SEOM).
Our clinical research focuses on gynecological malignancies and the development of novel therapies against these tumor types. We are also members of some of the most relevant societies and groups in gynecological oncology including the Gynecologic Cancer InterGroup (GCIG) as the Spanish representative for its Cervical Cancer and Phase II Trial Committees, and the Spanish clinical lead of the Gynecologic Oncology Group (GOG). We also belong to the European Network of Gynecological Oncology Trial groups (ENGOT).
Contributing to the advancement of the treatment of gynecological malignancies, we have participated in the development of a number of therapies that are now the current standard of care for different malignancies.
In 2021 we participated in several important clinical trials that have generated new and compelling data. As an example, we led the GARNET study. This trial includes the largest series of patients with endometrial cancer (EC) treated with immunotherapy; the anti-PD-1 agent, dostarlimab.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion in February 2021, recommending dostarlimab for the treatment of patients with EC who have progressed on platinum therapy.
While metastatic cervical cancer is a devastating disease, over recent years we have succeeded in expanding therapeutic approaches which have mainly been driven by immunotherapy. Moreover, we are working on other targeted agents such as neratinib that is showing promising results (Oaknin et al. 2020)*.
Our Principal Investigator, Ana Oaknin, serves on the Executive Board as Vice President for the Grupo Español de Investigación en Cáncer de Ovario – GEICO (the Spanish Ovarian Cancer Research Group); is Co-Chair of GCIG’s Cervical Cancer Committee; and a Faculty Member of the European Society for Medical Oncology’s (ESMO) Annual Meeting’s Gynecological Tumors Track (2019-2023) for which she was appointed as Chair at the ESMO 2019 Congress, 27 September – 01 October (Barcelona, Spain). She was also Discussant of the results of two phase III trials that were presented during the Track’s Presidential Symposium.
In 2021, Ana Oaknin was appointed as Subject Editor of ESMO’s Guidelines Committee, and was Co-Chair of the virtual International Gynecologic Cancer Society’s (IGCS) Annual Global Meeting, 30 August – 02 September, 2021.
* Oaknin A, Friedman CF, Roman LD, D'Souza A, Brana I, Bidard FC, Goldman J, Alvarez EA, Boni V, ElNaggar AC, Passalacqua R, Do KTM, Santin AD, Keyvanjah K, Xu F, Eli LD, Lalani AS, Bryce RP, Hyman DM, Meric-Bernstam F, Solit DB, Monk BJ. Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2020 Oct;159(1):150-156.
In 2021, Ana Oaknin was appointed as Subject Editor of ESMO’s Guidelines Committee, and was Co-Chair of the virtual International Gynecologic Cancer Society’s (IGCS) Annual Global Meeting, 30 August – 02 September, 2021.
Judith Balmaña is Principal Investigator of VHIO’s Hereditary Cancer Genetics Group and serves as Attending Physician for our Breast Cancer Unit, Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH). She graduated in Medicine from the Universitat Autònoma de Barcelona (UAB), and carried out her residency in Medical Oncology at the Hospital Sant Pau, Barcelona. She was then awarded with a grant from “La Caixa” and trained as a Clinical Research Fellow in the High-Risk Clinics for Breast and Colorectal Cancer at the Dana-Farber Cancer Institute, Boston (USA). She was awarded her PhD from the Universitat Autònoma de Barcelona for her research on a prediction model for hereditary colorectal cancer.
In 2015 she was a Visiting Researcher at the Abramson Cancer Center, Philadelphia (USA), working on multigene panel testing for hereditary breast cancer.
Judith is member of the Sociedad Española de Oncología Médica (SEOM), for which she has served as a Board Member of the Hereditary Cancer Section, Associate Faculty Member of the European Society of Medical Oncology (ESMO), for which she is currently appointed as Coordinator of the Cancer Genetics Group (2017 – 2021), Clinical Coordinator and teacher for the Genetic Counselling Master’s Program (IDEC/UPF) at the Universitat Pompeu Fabra (UPF), teacher of hereditary cancer at Universitat Internacional de Catalunya (UIC), member of the SOLTI Cooperative Group as well as the American Society of Clinical Oncology (ASCO) and chair of the HBOC-thematic group in the ERN-GENTURIS.
In 2005, she was appointed to set up the Vall d’Hebron University Hospital (HUVH) Medical Oncology Department’s Familial Cancer Program. Since then, she has been leading this program and serves as Attending Physician at HUVH’s Breast Cancer Unit. In 2016, Adrià López joined the group to research the psychological impact of multigene panel testing. In October 2018, VHIO’s Oncogenetics lab led by Sara Gutiérrez-Enríquez (formerly directed by Orland Díez), was incorporated within our group.
We focus on unravelling the challenges of implementing the advances in diagnosis of hereditary cancer susceptibility and translating insights into clinical practice. In collaboration with the hereditary cancer program at the Catalan Institute of Oncology (ICO) Judith obtained funding to investigate the genetic complexity of hereditary cancer through a multidimensional analysis of a customized panel, as well as the psychological impact in the population. Ongoing research is focused on the role of personality traits in predicting the psychological impact of genetic results and the uptake of prevention options.
A study to assess the genome-based cancer risk estimation and cancer-risk adapted strategies with the addition of polygenic risk score (PRS) analysis has just been funded. A longitudinal national-based registry of mutation carriers stores prospective data for health outcomes analysis.
Her interest in the genetic epidemiology of hereditary breast and ovarian cancer (HBOC) has resulted in a research collaboration with Sara Gutiérrez-Enríquez. This joint work has shed light on the characterization of new pathogenic variants in HBOC genes, and has provided discriminatory tools to interpret variants of uncertain significance in BRCA genes. We are interested in deciphering the role of intronic, splicing, and missense variants in major HBOC genes and investigating the yield of long-read RNA-seq in HBOC.
Sara Gutiérrez-Enríquez is also independently leading research into predictive genetic and cellular markers for susceptibility to radiotherapy-induced clinical toxicity. Her goal is to foster her independent research lines and ultimately become a group leader at VHIO.
With the discovery of PARP inhibitors, Judith became deeply involved in their clinical development as targeted therapy for patients with a BRCA1/2mutation. She has actively collaborated in phase I-III clinical trials with PARPi/other DNA-damaging agents targeting tumors with a BRCA deficiency. In 2012, she joined forces with Violeta Serra, Principal Investigator of VHIO’s Experimental Therapies Group to initiate and co-lead research aimed at identifying mechanisms of resistance to PARPi in breast cancers from BRCA1/2-mutation carriers.
Judith Balmaña is an ad-hoc reviewer for several international journals in oncology, and has published more than 180 papers in national and international biomedical publications of excellence.
Our group focuses on the clinical development of PARP inhibitors (PARPi) in early gBRCA1/2 breast cancer, and novel combinations in the advanced disease setting. We have consolidated our collaboration with VHIO’s Experimental Therapeutics Group led by Violeta Serra, which has resulted in a large collection of BRCA1/2-associated patient-derived xenografts (PDX) implanted in athymic mice.
We are using these murine models to identify mechanisms of resistance to targeted therapies, identify novel biomarkers, and assess new combinatorial treatments at disease progression. Our group has identified a functional biomarker for PARPi sensitivity that has been tested preclinically. We are now validating this biomarker in samples from clinical trials and in standard clinical practice.
We also focus on addressing the challenges associated with the implementation of advances in the diagnosis of hereditary cancer susceptibility and applying these insights in clinical practice. In partnership with the hereditary cancer program at the Catalan Institute of Oncology (ICO), we are investigating the genetic complexity of hereditary cancer through the multidimensional analysis of a customized panel and studying the psychological impact in our population.
Ongoing research centers on the role of personality traits in predicting the psychological impact of genetic results and the uptake of prevention strategies. We have received funding to assess genetic cancer risk estimation and cancer-risk adapted approaches including polygenic risk score (PRS) analysis. A longitudinal national-based registry of mutation carriers incorporates prospective data to explore health outcomes.
Led by our Senior Scientist, Sara Gutiérrez-Enríquez, we pursue our interest in the genetic epidemiology of hereditary breast and ovarian cancer (HBOC). This research has shed important light on the characterization of new pathogenic variants in HBOC genes, and provided discriminatory tools to interpret variants of uncertain significance in BRCA genes. We also aim to decipher the role of intronic, splicing, and missense variants in major HBOC genes and investigate the yield of long-read RNA-seq. In collaboration with VHIO’s Radiation Oncology Group led by Jordi Giralt, Sara Gutiérrez-Enríquez is independently leading research on predictive genetic and cellular markers of susceptibility to radiotherapy-induced clinical toxicity.
Rodrigo Dienstmann is a medical oncologist with expertise in clinical and translational research. After graduating in Brazil, he moved to Spain for training in the phase I development of cancer drugs. He helped develop a molecular prescreening strategy to match the genomic profile of each patient’s tumor to targeted agents, the central dogma of precision oncology.
During his post-graduation at the Massachusetts General Hospital (Boston, USA), he provided standardized decision support with structured reports of the next-generation sequencing tests performed in the clinical lab. By designing the framework for variant annotation, prioritization and interpretation, together with a comprehensive gene-drug knowledge database of predictive genomic biomarkers in solid tumors, he played a central role in the process of clinically implementing these tests.
He then assisted the Sage Bionetworks Computational Oncology team (Seattle, USA), in the development of novel predictive and prognostic models using cancer genomics data and was deeply involved in the Colorectal Cancer Subtyping Consortium, which resulted in the identification and characterization of the intrinsic disease subtypes.
He is now Principal Investigator of the Oncology Data Science Group and a coordinator of the Molecular Prescreening Program of the Vall d’Hebron Institute of Oncology, integrating clinical and translational research with multi-omics for precision cancer therapy and biomarker validation studies.
VHIO's ODysSey Group promotes translational research in precision oncology by integrating cancer molecular profiling data with clinical outcomes of oncology patients treated at the Vall d’Hebron University Hospital (HUVH).
To analyze big and real-world data, our group designs and maintains comprehensive clinical-molecular databases and develops customized decision-support systems for researchers who have an interest in correlative analyses for hypothesis-generation and biomarker validation. We also provide assistance to investigators for the calculation of sample size, clinical trial design, electronic case reporting and statistical analyses.
We also participate in international multi-omic data analyses projects, foster collaborative research in computational oncology, and are dedicated to connecting cancer researchers working on predictive and prognostic modelling, the identification of cancer drivers, molecular subtyping, primary-metastasis heterogeneity, microenvironment signatures and druggability in solid tumors.
Together with VHIO’s Cancer Genomics Group, Molecular Oncology Group and Early Clinical Drug Development Group, we co-lead VHIO's in-house Molecular Prescreening Program, and create informatics tools to explore and visualize multi-omics data for research purposes.
We provide support in the interpretation of next-generation sequencing tests and educate clinicians on emerging biomarkers. During Molecular Tumor Board meetings, we promote precision oncology by providing guidance regarding inclusion in early clinical trials with biomarker-guided targeted agents or immunotherapies, and genetic counseling alerts in the instance of pathogenic germline variants.
Jordi Giralt is Principal Investigator of the Radiation Oncology Group at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, Head of the Radiation Oncology Department at the Vall d’Hebron University Hospital (HUVH), and Professor in Radiation Oncology at the Universitat Autònoma de Barcelona (UAB). He is actively involved in translational research and technology development, with particular focus on EGFR-family as well as dose escalation programs in head and neck cancer. He is the head of the GEORCC (Spanish Group of Radiotion Oncology for Head and Neck Cancer.
He received his medical degree from the Universitat Autònoma de Barcelona and completed his specialist training in radiation oncology. He is a member of the European Society for Radiotherapy & Oncology (ESTRO), Pediatric Radiation Oncology Society (PROS), and the American Society of Radiation Oncology (ASTRO).
Jordi also serves on several Editorial Boards including those of Frontiers in Oncology, Oral Oncology, and Clinical Translational Oncology, and has (co) authored over 90 peer-reviewed papers. He has also been a member of Educational and Scientific Committees of the ESTRO, ECCO and PROS congresses and meetings.
Our group is integrated within the Radiation Oncology Department of the Vall d’Hebron University Hospital (HUVH), and focuses on the multidisciplinary treatment of patients with malignant tumors. We also participate either as Principal Investigators or research collaborators in a number of pioneering clinical trials, translational research projects, as well as technology development programs.
We recently renewed three LINACS thanks to a donation received from the Amancio Ortega Foundation. The machines incorporate all the very latest technology and the implementation of these highly complex techniques requires additional expertise from our service as well as specialized trainings for indications, administration procedures, quality control methods, as well as the incorporation of novel tools and approaches for the measurement of results.
Raquel Perez-Lopez attended Medical School at the Universitat de Barcelona and went on to complete her specialty training in Radiology at the Bellvitge University Hospital, Barcelona. During her residency, she completed a Masters in Clinical Sciences studying perfusion MRI inpatients with high-grade astrocytoma.
Supported by the European Society of Radiology (ESR), a clinical fellowship then led her to the Royal London Hospital – Barts Health NHS Trust, followed by her move to the Institute of Cancer Research and Royal Marsden, London (UK), where her PhD focused on the study of bonemetastases from prostate cancer by diffusion-weighted MRI.
These studies enabled her to identify the value of whole-body diffusion- weighted MRI as a prognostic and response biomarker of bone metastases in prostate which in turn led to the completion of the first prospective clinical trial in this context. Importantly, this work resulted inover fifteen manuscripts that she first or co-authored in prestigious titles including The New England Journal of Medicine, Cell, Cancer Discovery, and Radiology.
Raquel joined VHIO in the autumn of 2017 as Principal Investigator of its Radiomics Group. Herresearch focuses on functional CT and MRI techniques such as perfusion, diffusion and spectroscopy to better identify histological and molecular characteristics of tumors. In 2018 her group was awarded with an Institute of Health Carlos III (ISCIII) Program grant and Raquel received a Young Investigator Award from theProstate Cancer Foundation (PCF).
Complementing other preclinical and clinical research lines at VHIO, her group seeks to optimize drug development by more effectively characterizing the antitumor effect of novel agents (includingimmunotherapies), identify those patients who are most likely to benefit from these therapies, and also support VHIO´s translational research lines in genomics, predictive science, and biomarkers of response and resistance.
Our Radiomics Group continues to expand. In 2021, Camilio Monreal joined our team to set up and run our own computational server to provide new opportunities for the study of deep-learning and integrative multi-comics models. We are also pleased to announce that Olivia Prior, granted with a ”la Caixa” Foundation Doctoral INphINIT Fellowship, joined our group to explore non-invasive imaging biomarkers for better characterizing colorectal cancer (CRC). In collaboration with the Nuclear Medicine and Hematology Departments at the Vall Hebron University Hospital (HUVH), Maria Balaguer pursued her end-of-degree research project focused on PET/CT-radiomics for optimizing patient selection and monitoring response in patients with lymphoma treated with CAR-T cells.
Over the past year, we have fostered new collaborations with leading imaging research groups at Cardiff University (Wales, UK), the Champalimaud Foundation (Lisbon, Portugal), and the New York University School of Medicine (NY, USA). We have also forged new partnerships with other cutting-edge research institutes including the German Cancer Research Center - Deutsches Krebsforschungszentrum, DKFZ (Heidelberg, Germany), and the Uniklinikum Aachen University Hospital, RWTH Aachen (Aachen, Germany). Together, we have designed various projects for which we have applied for funding through national and international grants.
Continuing our collaboration with VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch led by Elena Garralda, and thanks to the support received through an AstraZeneca Partners of Choice Award, we are working on the PREDICT study to develop predictive biomarkers of response to immune checkpoint inhibitors by combining radiomics, genomics and the molecular characterization of the tumor microenvironment by multiplexed assays.
In 2021 we have also been awarded by the Asociación Española Contra el Cáncer - AECC (Spanish Association Against Cancer), to participate in a comprehensive project coordinated by Manuel Serrano, IRB Barcelona – Institute for Research in Biomedicine (Barcelona, Spain), to explore the role of senescence in cancer. By applying advanced magnetic resonance imaging (MRI), our group will develop novel, non-invasive biomarkers of this phenomenon to be tested in pre-clinical models as well as in patients.
We also participate in the EU-funded Cancer Core Europe Consortium’s DART project – Building Data Rich Clinical Trials, which is led by VHIO’s Elena Garralda. Aimed at optimizing clinical trial design, we are providing support to achieve image protocol standardization and integration of novel imaging biomarkers.
Our Group has recently joined the COLOSSUS Consortium – Advancing a Precision Medicine Paradigm in metastatic Colorectal Cancer: Systems based patient stratification solutions. This multi-center European Commission Horizon 2020-supported project aims to unravel new subtypes of RAS mutant colorectal cancer. Raquel Perez-Lopez leads and coordinates the medical imaging area of this project where she applies radiomics and machine learning models for exploring imaging phenotypes characteristic of these new sub-types, and predictive models of response to standard of care therapy.
We are also exploring new diffusion-weighted MRI protocols to evaluate biological-specific metrics regarding tissue cellularity and cell size in the liver. We envision that the metrics derived from this new assay will have important applications as non-invasive biomarkers in cancer. Francesco Grussu, a Post-Doctoral Fellow of our group, has been granted a Beatriu de Pinós post-doctoral fellowship this year to pursue this research.
Thanks to the support received from the Instituto de Salud Carlos III – ISCIII (Institute of Health Carlos III), and the Prostate Cancer Foundation’s (PCF) Young Investigator Award, our group coordinates a multi-center prospective study of whole-body diffusion-weighted MRI as a response biomarker of bone metastasis in prostate cancer patients. This study has now expanded to include breast cancer patients thanks to funding from La Marató de TV3 (PreciMet study).
We have established several interdisciplinary partnerships with various VHIO groups to work together on translational research projects. Our ethos of team science is key to optimizing imaging and accelerating translational research against cancer. Focused on applying imaging biomarkers and radiomics to cancer discovery, our efforts center on advancing precision imaging in personalized medicine to ultimately improve outcomes for cancer patients.
* Pons-Escoda A, Garcia-Ruiz A, Naval-Baudin P, Grussu F, Fernandez JJS, Simo AC, Sarro NV, Fernandez-Coello A, Bruna J, Cos M, Perez-Lopez R, Majos C. Voxel-level analysis of normalized DSC-PWI time-intensity curves: a potential generalizable approach and its proof of concept in discriminating glioblastoma and metastasis. Eur Radiol. 2022 Feb 1. Epub ahead of print.
Enriqueta Felip is Principal Investigator of VHIO’s Thoracic Cancer Group, within the Oncology Department of the Vall d’Hebron University Hospital (HUVH). Enriqueta Felip received her medical degree from the Universitat Autònoma de Barcelona, where she also completed her PhD studies in medical oncology. She is a Professor of Medicine at the Universitat de Vic – Universitat Central de Catalunya (UVic-UCC).
Enriqueta heads the management of thoracic cancer patients and is also responsible for lung cancer trials led by the Vall d´Hebron University Hospital’s (HUVH) Oncology Department. Current research lines include the optimization of chemotherapy in early-stage disease, evaluation of new agents and therapies, research into novel pharmacogenomic approaches, and the integration of immunotherapeutic approaches in the treatment of lung cancer patients, and the elucidation of potential mechanisms of resistance to tyrosine-kinase inhibitors.
In 2017 she was elected as Member of Foundation Council of the European Thoracic Oncology Platform (ETOP), and appointed Member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC) for the 2017-2021 term. Enriqueta was Co-Chair of the IALSC’s 20thWorld Conference on Lung Cancer (WCLC) Congress, 07-10 September 2019, Barcelona (Spain). She currently serves as President of the Oncology Commission at Vall d’Hebron University Hospital and is also a Member of the Scientific Advisory Committee of the Parc Taulí Sabadell Hospital in Barcelona.
Most recently, in October 2019, Enriqueta was elected as President-Elect of the Sociedad Española de Oncología Médica – SEOM (the Spanish Society of Medical Oncology), and now serves as SEOM’s President (2021-2023).
She is a Member of the Spanish Lung Cancer Group, SEOM, and the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the International Association for the Study of Lung Cancer (IASLC). She is author of numerous peer-reviewed articles and book chapters in the lung cancer field.
VHIO’s Thoracic Tumors & Head and Neck Cancer Group is dedicated to advancing cancer treatment and care for patients suffering from thoracic malignancies, including lung cancer, mesothelioma and thymic malignancies, and head and neck cancers. We focus on disease prevention, early detection and the more precise diagnosis and staging of disease toward improving clinical outcomes.
Our team strives to match currently available targeted therapies with specific molecular alterations identified in patients, unmask molecular mechanisms of acquired resistance, and optimize novel immunotherapy strategies.
For our patients with early stage thoracic malignancies, we collaborate closely with a multidisciplinary team incorporating thoracic surgeons, radiation therapists, radiologists, pulmonologists, pathologists, and biologists. In so doing, we are potentiating several treatment approaches and modalities. Given that our patients can suffer from severe symptoms our efforts also focus on ameliorating clinical outcomes by working in close connectivity with professionals across other disciplines.
Precision medicine for the treatment of advanced lung cancer is no longer an ambition. It is a guiding principle. We establish molecular determinants of disease in individual tumors and circulating cell-free DNA (cfDNA) by liquid biopsy, to more effectively tailor therapies to the specificities of each patient’s individual disease.
For patients with head and neck tumors we work alongside expert surgeons, radiotherapists, radiologists, pathologists, and nutritionists, and also lead a clinical trial program to assess novel immunotherapeutics and targeted agents in this particular setting.
Immune-based strategies have a role in the treatment algorithm for the management of non-small cell lung cancer; a number of protocols are now ongoing at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, led by Elena Garralda. Additionally, we contribute to VHIO’s early clinical drug development efforts. We also manage other less common thoracic malignancies including head and neck cancer, small cell lung cancer, mesothelioma, thymoma and neuroendocrine tumors.