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New hope for GIST: experimental combo targets hard-to-treat tumors

NCT ID NCT07406633

Disease control Sponsor: Kumquat Biosciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 5 times

Summary

This study tests whether adding an experimental drug (KQB198) to the standard cancer pill imatinib can shrink or control advanced gastrointestinal stromal tumors (GIST). About 46 adults with a specific gene mutation (KIT or PDGFRA) will receive the combination. The goal is to see if the combo is safe and works better than imatinib alone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

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

Started

Jun 2026

Expected to finish

Oct 2028

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 All Participants: * Unresectable or metastatic disease * Tissue confirmation of GIST * Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V). * Measurable disease per RECIST v1.1. * Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago. * Adequate organ function and performance status Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: * Unable to swallow or GI condition that prevents absorption. * Other active malignancies within the last 2 years. * History of hypersensitivity to any component of KQB198 or imatinib.

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm Digestive System Neoplasms gastrointestinal stromal tumor

As listed by the trial registrant

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

Gastro intestinal stromal tumour Gastrointestinal tumors GIST Gist - gastrointestinal stromal tumor Gist metastatic cancer

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Mayo Clinic - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northwell Health/R.J. Zuckerberg Cancer Center

    RECRUITING

    Lake Success, New York, 11042, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan Hospitals

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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