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A Study of FMC-376 for Advanced Solid Tumors with KRAS G12C Mutations

This study is testing a drug called FMC-376, given as an oral capsule daily, for people with advanced solid tumors that have a specific genetic change called a KRAS G12C mutation. To join, you must have solid tumors that are advanced (unresectable or metastatic) and have the KRAS G12C mutation. You should also have tried and not responded to standard treatments, or if standard treatment isn't suitable. The study will look at how safe FMC-376 is by tracking side effects and other problems for up to 24 months. The goal is to find the right dose and see how well it works. This study is currently unclear about its recruitment status and plans to enroll about 403 participants.

Study design
This study is an interventional trial with an unclear status, planning to enroll 403 participants. It will be conducted in three parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse Events (AEs) will be measured for approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06244771

A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Frontier Medicines Corporation
~403 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:FMC-376

At a glance

Recruiting sites
23 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicities
Measured over Up to 21 Days
+1 more outcome measured

Conditions

Advanced Solid Tumors With KRAS G12C Mutations
Solid Tumor, Adult
Unresectable Solid Tumor
Metastatic Solid Tumor
Non Small Cell Lung Cancer
Colorectal Cancer
KRAS G12C
Pancreatic Cancer

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Where it's being run

26 sites across 20 states
Texas4
California3
South Australia2
Florida1
Indiana1
Kansas1
Massachusetts1
Michigan1

Study leadership

  • Medical Lead · STUDY_DIRECTOR · Frontier Medicines Corporation

Who to contact

Medical Lead
[email protected]
+1 (650) 457-1005
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Dose Limiting ToxicitiesUp to 21 Days

    Number of participants with Dose Limiting Toxicities (DLTs)

  • Adverse Events (AEs)Approximately 24 Months

    Number of participants with treatment-emergent adverse events (TEAEs)