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?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
* 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
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
* 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.