Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors

May 27, 2026 updated by: Cogent Biosciences, Inc.

Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Available
        • Mayo Clinic Hospital
    • California
      • Los Angeles, California, United States, 90095
        • Available
        • UCLA Department of Medicine- Hematology/Oncology
      • Los Angeles, California, United States, 90033
        • Available
        • USC/Norris Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Available
        • Smillow Cancer Hospital - Yale New Haven Health
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Clinic
      • Orlando, Florida, United States, 32806
        • Available
        • Orlando Health
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • Available
        • The University of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute (DFCI)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Available
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
      • Maumee, Ohio, United States, 43537
        • Available
        • Taylor Cancer Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Available
        • UPMC Hillman Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Available
        • Huntsman Cancer Institute, University of Utah
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Available
        • Shenandoah Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cogent Biosciences, Inc.

Investigators

  • Study Director: Rachael Easton, MD, PhD, Cogent Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGT9486-EAP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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