Testing a new cancer drug for a specific genetic mutation

Plain-English translation of NCT06040541 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated August 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called , which is designed to target a specific genetic change (KRAS G12D mutation) found in certain advanced cancers. Researchers want to learn whether this treatment is safe, how well it works, and how the body processes it. The study will also test whether combining this medication with another drug called might be more effective.

Many cancers have a KRAS G12D genetic mutation that makes them grow and spread. Current treatments don't always work well for these cancers, and there's a real need for new options. This medication is designed specifically to target this mutation and stop cancer cells from growing.

Do you qualify?

You likely qualify if…

you have been diagnosed with an advanced solid tumor (like lung, colorectal, or pancreatic cancer) with the KRAS G12D genetic mutation
your cancer has progressed despite previous treatments, or you couldn't tolerate those treatments
you are in good enough overall health to participate (measured by your doctor's assessment)
your organs are working well enough to handle the study medication

You likely don't qualify if…

you have primary brain tumors or active brain metastases (cancer that has spread to your brain)
you have cancer that has spread to the lining around your brain or spinal cord compression
you have difficulty swallowing or absorbing oral medications because of stomach or digestive problems
you have previously taken any KRAS-targeted therapy, including other KRAS G12D inhibitors or RAS inhibitors

What participation looks like

You would take a daily oral medication (a pill) at home. The study has two main tracks: one tests the medication alone, and the other tests it combined with a second drug. You'll start with a dose-finding phase to determine the right amount for you, then move to a larger phase where researchers continue monitoring your safety and how well the medication works. Throughout the trial, you'll have regular visits with the study team for blood work, scans, and check-ins on how you're feeling.

AI-generated summary from trial data · Aug 5, 2026 · Not medical advice

Trial locations(17 sites)

United States

University of California, Davis Comprehensive Cancer Center, Sacramento, California

Smilow Cancer Hospital (Yale University), New Haven, Connecticut

Florida Cancer Specialists, Sarasota, Florida

Lee Moffitt Cancer Center, Tampa, Florida

Johns Hopkins University, Baltimore, Maryland