Unidad de Fases I - START Madrid

Unidad de Fases I - START Madrid

o   A Phase 1, Multi-center, Open Label First-in-Human Study with ABBV-CLS-579 Alone and in Combination in Subjects with Solid Tumors.

Investigador Principal: Dr. Emiliano Calvo 

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o  A Phase 1 Study with ABBV-CLS-484 Alone and in Combination in Subjects with Locally Advanced or Metastatic Tumors.

Investigador Principal: Dr. Emiliano Calvo

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o  Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibito.

Investigador Principal: Dr. Emiliano Calvo

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o  A PHASE 1 DOSE ESCALATION STUDY TO ASSESS SAFETY AND EFFICACY OF ADP-A2M4CD8 IN HLA-A2+ SUBJECTS WITH IMAGE-A4 POSITIVE TUMORS

Investigador Principal: Dr. Emiliano Calvo

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o  Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies

Investigador Principal: Dr. Emiliano Calvo

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o  Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies.

Investigador Principal: Dr. Emiliano Calvo

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o  Phase I/IIa Study in Patients with CLDN6-positive solid tumors

Investigador Principal: Dr. Emiliano Calvo

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o  A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors

Investigador Principal: Dr. Emiliano Calvo

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o  A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors PIQ follow up

Investigador Principal: Dr. Emiliano Calvo

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o  A Phase 1/2 Study of BMS-986449 with and without Nivolumab or Nivolumab and Ipilimumab.

Investigador Principal: Dr. Emiliano Calvo

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o  A study in people with advanced cancer to test whether the amount of BI 907828 in the blood is influenced by taking OATP inhibitor.

Investigador Principal: Dr. Emiliano Calvo

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o   First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors.

Investigador Principal: Dr. Emiliano Calvo

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o   First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors.

Investigador Principal: Dr. Emiliano Calvo

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o   First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate the safety of GEN1053 as monotherapy and as combination therapy in subjects with malignant solid tumors.

Investigador Principal: Dr. Emiliano Calvo

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o   A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers.

Investigador Principal: Dr. Emiliano Calvo

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o   An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors.

Investigador Principal: Dr. Emiliano Calvo

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o   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.

Investigador Principal: Dr. Emiliano Calvo

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o   A Phase I Dose Escalation Study of OMX0407 a Salt-inducible Kinase inhibitor in patients with previously treated unresectable solid tumours.

Investigador Principal: Dr. Emiliano Calvo

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o   A Phase 1 Study of JNJ-78278343, a T Cell Redirecting Agent Targeting Human Kallikrein-2 (KLK2), for Advanced Prostate Cancer.

Investigador Principal: Dr. Emiliano Calvo

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o   A Phase 1, open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cell engager, in patients with therapy refractory metastatic castration resistant prostate cancer.

Investigador Principal: Dr. Emiliano Calvo

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o    Phase I/II, multi-center, open label study of DYP688 in patients with metastatic uveal melanoma (MUM) and other GNAQ/11 mutant melanomas..

Investigador Principal: Dr. Emiliano Calvo

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o    A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation.

Investigador Principal: Dr. Emiliano Calvo

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o    AN OPEN LABEL, MULTICENTER, DOSEESCALATION, PHASE 1 STUDY TO EVALUATE SAFETY/TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY ANTITUMOR ACTIVITY OF RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.

Investigador Principal: Dr. Emiliano Calvo

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o    A Phase 1, open-label, multicenter, safety study of SAR442720 in combination with pembrolizumab in patients with advanced malignancies.

Investigador Principal: Dr. Emiliano Calvo

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o    A Phase 1/1b open-label, first-in-human, single agent, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR443216 in participants with relapsed/refractory HER2 expressing solid tumors.

Investigador Principal: Dr. Emiliano Calvo

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o     An open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and as a combination therapy in adult subjects with advanced or metastatic solid tumors.

Investigador Principal: Dr. Emiliano Calvo

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o     A Phase 1 Study of SGN-B6A in Advanced Solid Tumors.

Investigador Principal: Dr. Emiliano Calvo

Mas información aquí

 

o     A FIRST IN HUMAN PHASE 1/2 OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND EXPANSION STUDY OF SINGLE-AGENT PRS-344/S095012 IN PATIENTS WITH SOLID TUMOR.

Investigador Principal: Dr. Emiliano Calvo

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o     A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity ofTNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors.

Investigador Principal: Dr. Emiliano Calvo

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o     A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients with HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+Solid Tumors that Either Have No Further Approved Therapeutic Alternative(s) or are in a Non-Curable State and Have Received a Minimum of Two Lines of Systemic Therapy.

Investigador Principal: Dr. Emiliano Calvo

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o     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 Cancer.

Investigador Principal: Dra. Irene Moreno

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o     Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression.

Investigador Principal: Dra. Irene Moreno

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o     A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies.

Investigador Principal: Dra. Irene Moreno

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o     A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies.

Investigador Principal: Dra. Irene Moreno

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o     Phase 1/1b Open-label, Multicenter Study.

Investigador Principal: Dra. Irene Moreno

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o     Phase II Study in Patients with advanced NSCLC, mCRPC, advanced Solid Tumors.

Investigador Principal: Dra. Irene Moreno

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o     A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors.

Investigador Principal: Dra. Irene Moreno

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o     A Phase 1 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Tinostamustine, a Novel Alkylating and Deacetylase Inhibiting Molecule, as Adjuvant Treatment in Patients with Newly Diagnosed Unmethylated MGMT-promoter Glioblastoma.

Investigador Principal: Dra. Irene Moreno

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o     A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent.

Investigador Principal: Dra. Irene Moreno

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o     A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OFPF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITHRELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC),CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULARLYMPHOMA (FL).

Investigador Principal: Dra. Irene Moreno

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o  An Open-Label, Multicenter, Pharmacokinetic Study of Lurbinectedin in Patients with Advanced Solid Tumors and Varying Degrees of Hepatic Impairment

Investigador Principal: Dra. Irene Moreno

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o  A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY‑4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

Investigador Principal: Dra. Irene Moreno

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o  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)

Investigador Principal: Dra. Irene Moreno

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o  TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II

PLATFORM TRIAL

Investigador Principal: Dra. Irene Moreno

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o  A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH MELANOMA (MORPHEUS-MELANOMA

Investigador Principal: Dra. Irene Moreno

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o  A Phase Ib/II, open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of MuLtiple Treatment Combinations in Patients with breast cancer (Morpheus‑breast cancer)

Investigador Principal: Dra. Irene Moreno

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o  A PHASE Ib/II, OPEN-LABEL, MULTICENTER,RANDOMIZED UMBRELLA STUDY EVALUATINGTHE EFFICACY AND SAFETY OF MULTIPLEIMMUNOTHERAPY-BASED TREATMENTCOMBINATIONS IN PATIENTS WITH LOCALLYADVANCED OR METASTATIC UROTHELIALCARCINOMA AFTER FAILURE WITHPLATINUM-CONTAINING CHEMOTHERAPY(MORPHEUS-mUC)

Investigador Principal: Dra. Irene Moreno

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o    A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors Site Pre-Study Visit Follow-Up Letter

Investigador Principal: Dra. Irene Moreno

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o     A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (zalifrelimab) Administered Intravesically as Monotherapy and in Combination with Other Agents in Patients with Recurrent Non-muscle Invasive Bladder Cancer (NMIBC). 

Investigador Principal: Dra. Irene Moreno

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o      A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcRIIB), in Combination with Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma that has Relapsed or is Refractory to Rituximab

Investigador Principal: Dra. Irene Moreno

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o      A first-in-human dose-escalation and expansion study with the SIRPadirected monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory CD20 positive Bcell Non-Hodgkin Lymphoma (NHL)

Investigador Principal: Dr. Pérez de Oteyza

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o      An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with advanced haematological malignancies.

Investigador Principal: Dr. Pérez de Oteyza

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o      A Phase 1 First in Human Study of the Menin-MLL (KMT2A) Inhibitor 

Investigador Principal: Dr. Pérez de Oteyza

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o      This is a phase 1b study of the combination of REGN5458 and standard of care regimens in relapsed/refractory myeloma. 
Investigador Principal: Dr. Pérez de Oteyza

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o      A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562  
Investigador Principal: Dr. Ramón

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o      A First-in-Human, Multi-center, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects with Advanced Solid Tumors  
Investigador Principal: Dr. Ramón

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o      Phase 1 FIH study with ABBV-400, an antibody drug conjugate (ADC) consisting of a c-Met targeting antibody conjugated to a potent topoisomerase 1 (Top1) inhibitor payload. This c-Met targeting antibody, is the same antibody on Telisotuzumab vedotin (ABB-V399), which recently received FDA breakthrough status. The FIH study (M21-404) will evaluate patients with solid tumors known to express c-Met with a primary focus in NSCLC and GEA

Investigador Principal: Dra de Miguel

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o      Prospective collection of donor tissue and blood or leukapheresis product from patients with solid tumours to enable development of methods for the manufacturing of clonal neoantigen T cell products (cNeT).

Investigador Principal: Dra de Miguel

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o      An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)

Investigador Principal: Dra de Miguel

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o      A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT601) Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
Investigador Principal: Dra de Miguel

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o      Clinical and Immunologic Activity of Nemvaleukin Alfa With a Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients (ARTISTRY-3). 

Investigador Principal: Dra de Miguel

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o      A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic HER2-Expressing Cancers
Investigador Principal: Dra de Miguel

Mas información aquí

 

o      A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

Investigador Principal: Dra de Miguel

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o      An open label, first-in-human study of BAY 2927088 in participants with advanced non-small cell lung cancer (NSCLC) harboring an EGFR and/or HER2 mutation in patients with advanced cancer harboring an EGFR and/or HER2 mutation

Investigador Principal: Dra de Miguel

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o      LuCa-MERIT-1: First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer

Investigador Principal: Dra de Miguel

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o      A Phase 1/2 Study of BMS-986408 with and without Nivolumab or Nivolumab and Ipilimumab in Participants with Solid Tumors

Investigador Principal: Dra de Miguel

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o      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

Investigador Principal: Dra de Miguel

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o     A Phase 1, dose-escalation and expansion study to assess safety and preliminary antitumor activity of Debio 0123 in combination with carboplatin and etoposide in adult participants with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy
Investigador Principal: Dra de Miguel

Mas información aquí

 

o     A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in combination with nivolumab in adults with advanced solid tumors

Investigador Principal: Dra de Miguel

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o     A PHASE 1b DOSE ESCALATION AND DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF FURMONERTINIB IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH ACTIVATING EGFR OR HER2 MUTATIONS, INCLUDING EXON 20 INSERTION MUTATIONS
Investigador Principal: Dra de Miguel

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o     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

Investigador Principal: Dra de Miguel

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o     A PHASE Ia/Ib DOSE-ESCALATION AND DOSEEXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION

Investigador Principal: Dra de Miguel

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o     A phase II, Single-Arm, open label study evaluating the safety and pharmacokinetics of the intravenous fixed-dose combination (IV FDC) of Tiragolumab and Atezolizumab in participants with locally advanced, recurrent or metastatic solid tumors

Investigador Principal: Dra de Miguel

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o     A First-in-Human, Open-label, Dose-escalation Trial with Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects with Malignant Solid Tumors

Investigador Principal: Dra de Miguel

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o     A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (anti-BTLA antibody) as a Single Agent and in Combination with Tislelizumab (anti-PD-1 antibody) in Adult Patients with Advanced Solid Tumors

Investigador Principal: Dra de Miguel

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o     A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer

Investigador Principal: Dra de Miguel

Mas información aquí

 

o     A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive 

Investigador Principal: Dra de Miguel

Mas información aquí

 

o     Multicentre, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours

Investigador Principal: Dra de Miguel

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o     A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation

Investigador Principal: Dra de Miguel

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o     A Phase Ib/II, multicenter, open-label dose escalation and expansion platform study of JDQ443 with select combinations in patients with advanced solid tumor harboring the KRAS G12C mutation

Investigador Principal: Dra de Miguel

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o     A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors

Investigador Principal: Dra de Miguel

Mas información aquí

 

o     A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Investigador Principal: Dra de Miguel

Mas información aquí

 

o     Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors

Investigador Principal: Dra de Miguel

Mas información aquí


 o     Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors

Investigador Principal: Dra de Miguel

Mas información aquí

 

o     Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients with Selected Advanced Solid Tumors" con código de protocolo: PM534-A-001-22
Investigador Principal: Dra de Miguel

Mas información aquí

 

o     A Phase I Study of REGN6569, an anti-GITR mAb, with cemiplimab in patients with advanced solid tumor malignancies
Investigador Principal: Dra de Miguel

Mas información aquí


o    An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Investigador Principal: Dra de Miguel

Mas información aquí

 

o    Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors (MINOTAUR Study
Investigador Principal: Dra de Miguel

Mas información aquí

 

o    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)
Investigador Principal: Dra de Miguel

Mas información aquí

 

o     Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations
Investigador Principal: Dra de Miguel

Mas información aquí

 


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