An Open-Label, Phase I/II Dose-Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRASG12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors
Details
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
You can join if...
Inclusion Criteria:
-Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
-You 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
-You agree 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