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RecruitingPhase 1 / Phase 2

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 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests FMC-376 in people with advanced solid tumors that have a gene change called KRAS G12C. The study has 3 parts and will test different doses.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid tumor confirmed by a tissue or cell test, with the KRAS G12C gene change.
  • The cancer has grown into nearby areas and cannot be removed by surgery, or has spread to other parts of the body.
  • Past standard treatment did not stop the cancer from growing or caused side effects you could not tolerate; standard treatment is not suitable; or an experimental drug is considered standard care.
  • Are fully active, or can do light work but have trouble with hard physical activity.
  • Have blood counts, kidneys, and liver that work well enough for the study.
  • Agree not to join another study that tests a treatment while taking the study drug.

Who can't join

  • Have cancer in the tissue or fluid around the brain and spinal cord.
  • Have serious ongoing side effects from past cancer treatments.
  • Have a known or suspected allergy to FMC-376 or any of its ingredients.
  • Have a condition that affects how your body absorbs the study drug.
  • Have an illness or medical history that could affect your safety, your ability to follow study rules, or how researchers understand the results.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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

Study sites (15)

CA

FL

IN

KS

MA

MI

PA

TX

UT

VA