A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 19, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
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: Oct 19, 2026. Always confirm current availability with the study team.