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A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients with Advanced or Metastatic Solid TumorsA Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients with Advanced or Metastatic Solid TumorsTo evaluate the safety and tolerability of BH3120 administered intravenously (IV) in subjects with advanced or metastatic solid tumors.ClinicalTrials.gov registration not requiredJohn Sarantopoulos MD
Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET) Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET) Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid TumorsClinicalTrials.gov registration not requiredJohn Sarantopoulos MD
A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients with Advanced Metastatic Castration Resistant Prostate Cancer A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients with Advanced Metastatic Castration Resistant Prostate Cancer This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC.ClinicalTrials.gov registration not requiredJohn Sarantopoulos MD
A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients with Advanced or Metastatic Solid Tumors A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients with Advanced or Metastatic Solid Tumors This is a phase Ia/Ib, open-label, dose-escalation and dose-expansion study designed to evaluate BSI-082 monotherapy and combined therapy with Trastuzumab deruxtecan (T-DXd) in patients with locally advanced or metastatic solid tumors.ClinicalTrials.gov registration not requiredJohn Sarantopoulos MD
A First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesA First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesM22-716 is a Phase 1, FIH, open-label, dose escalation, dose expansion, biomarker/pharmacodynamic (PD) study of ABBV-319 in participants with relapsed or refractory (R/R) B-cell malignancies.NCT05512390Daruka Mahadevan, MD, PhD
A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsA Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsTo evaluate the safety, tolerability, MTD and the RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD
An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (PROSPER)An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (PROSPER)This is an open-label, Phase 1/2, dose escalation, dose expansion and cohort expansion study to evaluate the safety, tolerability, PK, PD and clinical activity of FMC-376 in participants with locally advanced unresectable or metastatic solid tumors which harbor KRAS G12C mutation.NCT06244771Daruka Mahadevan, MD, PhD
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY FOR LNCB74, A B7-H4 TARGETED ANTIBODY DRUG CONJUGATE, AS MONOTHERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORSA PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY FOR LNCB74, A B7-H4 TARGETED ANTIBODY DRUG CONJUGATE, AS MONOTHERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORSThe first-in-human clinical study will be a Phase 1, multicenter, open-label, multiple dose, two-part study of LNCB74 that will include Dose Escalation (Part 1) and Dose Expansion/Optimization (Part 2). The objectives of this study will be to determine the safety and tolerability, define the maximum tolerated dose (MTD), maximal administered dose (MAD) and/or the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of LNCB74 in participants with advanced or metastatic solid tumors.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD
A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid TumorsA Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid TumorsPart 1 (dose escalation): to evaluate the safety and tolerability of SIM0505 and determine the maximum tolerated dose (MTD)NCT06792552Daruka Mahadevan, MD, PhD
A Multi-center, Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of YL205 in Patients with Advanced Solid TumorsA Multi-center, Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of YL205 in Patients with Advanced Solid TumorsThis is a multi-center, open-label, Phase I/II clinical study of YL205. This study includes: Phase I dose escalation and backfill, and Phase II dose expansion. It is to evaluate the safety and tolerability of YL205 in patients with advanced solid tumors who have experienced treatment failure of existing standard therapies, have no standard treatment options, are currently not suitable for standard treatments, or cannot benefit from other approved therapies in dose escalation, and will backfill patients in certain tolerable dose levels to further evaluate the efficacy and safety of YL205.NCT06459973Daruka Mahadevan, MD, PhD