A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers

Official Title

A Phase 1b/2a Two-Part, Open-Label, Multicentre Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers

Summary:

This study will investigate OC-001 as monotherapy, and in combination with an anti-Programmed Cell Death Protein-1 (PD-1) or anti-Programmed Cell Death Ligand-1 (PD-L1) Antibody inhibitor, in various cancer types

Trial Description

Primary Outcome:

• Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
• Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a

• Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
• Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
• Time to reach OC-001 Cmax (Tmax) in Phase 1b
• Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
• Overall Response Rate (ORR) in Phase 2a
• Progression Free Survival (PFS) in Phase 2a
• Duration of Response (DOR) in Phase 2a
• Time to Response (TTR) in Phase 2a
• Disease Control Rate (DCR) in Phase 2a
• Overall Survival (OS) in Phase 2a
• One-Year Survival Rate in Phase 2a
• Maximum Observed OC-001 Concentration (Cmax) in Phase 2a
• Minimum Observed OC-001 Concentration (Cmin) in Phase 2a

View this trial on ClinicalTrials.gov