Home › Metastatic Cancer › NCT06244771
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 * NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate) * 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 * For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis 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 * For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.
About the study
The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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.
What is being tested
- FMC-376 (drug)
Sponsor: Frontier Medicines Corporation · Participants: 293 · Started: Feb 12, 2024
Contact the study team
- Medical Lead · Phone: +1 (650) 457-1005
Official record on ClinicalTrials.gov — NCT06244771
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.