AN OPEN-LABEL, PHASE 1/2 DOSE ESCALATION, DOSE EXPANSION AND COHORT EXPANSION STUDY EVALUATING THE SAFETY, PK AND CLINICAL ACTIVITY OF FMC-376 MONOTHERAPY AND IN COMBINATION WITH PEMBROLIZUMAB IN PARTICIPANTS WITH KRAS G12C MUTATED ADVANCED SOLID TUMORS (PROSPER)
Trial Description
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced
solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts:
Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion).
Multiple dose levels in participants with advanced solid tumors will be evaluated.
Eligibility Requirements
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced unresectable or
metastatic solid tumors with KRAS G12C mutation
- Received and progressed or been intolerant to prior standard therapy OR standard
therapy is considered inappropriate OR an investigational agent is considered
standard of care
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, and hepatic function
- Agrees not to participate in another interventional study while receiving study drug
Exclusion Criteria:
- Leptomeningeal disease or carcinomatous meningitis
- Clinically significant toxicity resulting from prior cancer therapies
- Known or suspected hypersensitivity to FMC-376 or any components of the study drug
- Condition that would interfere with study drug absorption
- Any illness or medical history that would impact safety or compliance with study
requirements or impact ability to interpret study data