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A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06244771.
