A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
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.
Checked against the public recordLast updated Mar 18, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Frontier Medicines Corporation
- Interventions being studied
- Drug: FMC-376
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer CenterLa Jolla, California
- University of California Irvine (UCI) - Chao Family Comprehensive Cancer CenterOrange, California
- University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Florida Cancer Specialists and Research InstituteLake Mary, Florida
- Northwest Cancer CentersDyer, Indiana
- The University of Kansas Cancer CenterFairway, Kansas
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- University of PennsylvaniaPhiladelphia, Pennsylvania
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Community Clinical TrialsKingwood, Texas
- South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2026. Always confirm current availability with the study team.