Testing a new cancer drug for tumors with a specific genetic mutation

Plain-English translation of NCT06244771 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new drug called designed to treat advanced cancers that have a specific genetic change (KRAS G12C mutation). The study will test different doses of the medication to find the safest and most effective dose, and to see how well it works against these hard-to-treat tumors. Researchers will track how your body handles the treatment and whether it helps shrink your cancer.

Many people with advanced cancers that have this specific genetic mutation have limited treatment options, especially if they've already tried standard therapies or can't tolerate them. This trial exists to see if this new medication could offer a better path forward for patients with these difficult-to-treat cancers.

Do you qualify?

You likely qualify if…

you have been diagnosed with an advanced, unresectable, or metastatic solid tumor with a KRAS G12C genetic mutation
you have already received and your cancer progressed on standard therapy, or you couldn't tolerate standard therapy, or standard therapy isn't right for you
you are in good enough overall health to participate (ECOG performance status 0 or 1, meaning you can carry out daily activities with little or no assistance)
you have adequate blood counts, kidney function, and liver function based on recent lab tests
you are willing not to enroll in another experimental treatment study while taking part in this trial

You likely don't qualify if…

you have cancer that has spread to the lining of your brain or spinal cord
you have experienced serious, ongoing side effects from previous cancer treatments
you are known to be allergic to FMC-376 or any of its ingredients
you have a medical condition that would prevent your body from absorbing the medication properly
you have another illness or medical history that your doctor believes would make it unsafe for you to participate

What participation looks like

You would take the medication in 21-day cycles, with the dose and schedule determined by which phase and cohort you're enrolled in. The trial has three parts: an initial dose-finding phase, a dose-expansion phase to test the best dose in more patients, and a final phase to test the medication in specific cancer types. You would have regular visits with the research team for check-ups, blood tests, and imaging scans to monitor how the treatment is working and watch for side effects.

AI-generated summary from trial data · Jun 27, 2026 · Not medical advice

Trial locations(26 sites)

United States

University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center, La Jolla, California

University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center, Orange, California

University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center, San Francisco, California

Florida Cancer Specialists and Research Institute, Lake Mary, Florida

Northwest Cancer Centers, Dyer, Indiana