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New drug combo offered to GIST patients with no other options

NCT ID NCT06948955

Disease control Sponsor: Cogent Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This expanded access program provides bezuclastinib, an investigational drug, combined with sunitinib for adults with advanced gastrointestinal stromal tumors (GIST) who cannot tolerate or have progressed on imatinib. The goal is to offer a potential treatment when no satisfactory alternatives exist. Participants must meet specific health criteria and commit to the program's assessments.

What this could mean

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

Active substance
bezuclastinib and sunitinib
What this could lead to
If this combination works, it could provide a new treatment option for people with advanced GIST who have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so data on effectiveness and safety is limited. The combination may not work for everyone and could cause side effects.

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.

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

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: * Able to provide written informed consent and commit to recommended EAP assessments. * ≥18 years of age. * Able to swallow tablets. * Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. * Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression. * Meet clinically acceptable local laboratory results. Exclusion Criteria: * Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial. * Prior or known intolerance to sunitinib. * Patients who have previously participated in a bezuclastinib clinical trial. * Patients with persistent \> Grade 2 toxicities from prior therapy. * Known PDGFR driving mutations or known SDH deficiency. * Pregnant or currently breastfeeding. Other protocol-defined criteria apply.

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Conditions

The condition(s) this trial relates to.

digestive system neoplasm gastrointestinal stromal tumor

As listed by the trial registrant

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

Gastrointestinal neoplasms, gastrointestinal stromal tumors

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

    26 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

Locations

  • Cleveland Clinic Foundation

    AVAILABLE

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute (DFCI)

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Huntsman Cancer Institute, University of Utah

    AVAILABLE

    Salt Lake City, Utah, 84112, United States

  • Johns Hopkins University

    AVAILABLE

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Institute

    AVAILABLE

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • Mayo Clinic

    AVAILABLE

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    AVAILABLE

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital

    AVAILABLE

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    AVAILABLE

    New York, New York, 10065, United States

  • Northwest Medical Specialties

    AVAILABLE

    Tacoma, Washington, 98405, United States

    Contact Email: •••••@•••••

  • Northwestern Memorial Hospital

    AVAILABLE

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Oregon Health and Sciences University

    AVAILABLE

    Portland, Oregon, 97239, United States

  • Orlando Health

    AVAILABLE

    Orlando, Florida, 32806, United States

  • Roswell Park Cancer Institute

    AVAILABLE

    Buffalo, New York, 14263, United States

  • Shenandoah Oncology

    AVAILABLE

    Winchester, Virginia, 22601, United States

  • Shenandoah Oncology

    AVAILABLE

    Winchester, Virginia, 22601, United States

  • Smillow Cancer Hospital - Yale New Haven Health

    AVAILABLE

    New Haven, Connecticut, 06510, United States

  • Taylor Cancer Research Center

    AVAILABLE

    Maumee, Ohio, 43537, United States

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    AVAILABLE

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medical Center

    AVAILABLE

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • Thomas Jefferson University

    AVAILABLE

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Department of Medicine- Hematology/Oncology

    AVAILABLE

    Los Angeles, California, 90095, United States

  • UPMC Hillman Cancer Center

    AVAILABLE

    Pittsburgh, Pennsylvania, 15232, United States

  • USC/Norris Comprehensive Cancer Center

    AVAILABLE

    Los Angeles, California, 90033, United States

  • University of Colorado

    AVAILABLE

    Aurora, Colorado, 80045, United States