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.
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
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
Sequential
FMC-376
DrugOral Capsule Daily
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs)
Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs)
Maximum Observed Plasma Concentration (Cmax) of FMC-376
Cmax
Time to Reach Maximum Blood Concentration (Tmax) of FMC-376
Tmax
Minimum Observed Plasma Concentration (Cmin) of FMC-376
Cmin
Elimination Half-life (t1/2) of FMC-376
t1/2
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