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New pill targets Hard-to-Treat cancers with a specific gene mutation

NCT ID NCT06040541

Disease control Sponsor: Revolution Medicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called RMC-9805, taken as a pill, in adults with advanced solid tumors (such as lung, colorectal, or pancreatic cancer) that have a specific mutation in the KRAS gene called G12D. The drug is given alone or in combination with another oral drug, RMC-6236. The main goals are to check safety, find the right dose, and see how the body handles the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RMC-9805 (oral tablet) and RMC-6236 (oral tablet)
What this could lead to
If successful, this could lead to a new targeted treatment option for people with hard-to-treat cancers that have a KRAS G12D mutation.
What could go wrong
This is an early-phase trial (Phase 1/1b) focused on safety and dosing, so it is not yet known if the drug will shrink tumors or improve survival. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 604 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage * ECOG performance status 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Known or suspected leptomeningeal or active brain metastases or spinal cord compression * Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication * Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors) Other inclusion/exclusion criteria may apply.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm digestive system neoplasm lung neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Colorectal cancer (CRC) Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma (PDAC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Carolina BioOncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lee Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • START

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Mary Crowley

    RECRUITING

    Dallas, Texas, 75230, United States

  • Smilow Cancer Hospital (Yale University)

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of California, Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Texas, MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.