FMC-376 for Advanced KRAS G12C Solid Tumors

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

Recruiting Phase 1 Phase 2 Interventional Study
Advanced Solid Tumors With KRAS G12C Mutations Solid Tumor, Adult Unresectable Solid Tumor Metastatic Solid Tumor Non Small Cell Lung Cancer KRAS G12C
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
293 (estimated)
Sponsor
Frontier Medicines Corporation · Industry
Who this trial is looking for

This trial is looking for people with advanced solid tumors that have a specific genetic mutation called KRAS G12C. Participants will take a drug called FMC-376 and the trial will evaluate how it works in different doses.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have cancer that is advanced and cannot be surgically removed.
  • I have a confirmed KRAS G12C mutation.
  • I have tried standard treatments but they didn't work for me or I can't take them.
  • I have a good performance status (look after myself).
  • I have normal blood, kidney, and liver function.
  • I agree not to take part in another study while on this trial.

You may not be able to join if

  • I have leptomeningeal disease or cancer in my brain.
  • I have serious side effects from previous cancer treatments.
  • I am allergic to FMC-376 or any of its ingredients.
  • I have a condition that affects how the drug is absorbed.
  • I have other medical issues that could affect my safety or following the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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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 cons…
Contacts

Medical Lead

+1 (650) 457-1005

clinicaltrials@frontiermeds.com

CONTACT