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

July 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alexandra Malinowski, PharmD
  • Phone Number: 1-877-633-8049
  • Email: EAP@cogentbio.com

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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Available
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute (DFCI)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Available
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic
    • New York
      • Buffalo, New York, United States, 14263
        • Available
        • Roswell Park Cancer Institute
      • 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
    • Oregon
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health and Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Available
        • Thomas Jefferson University
      • 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
    • Washington
      • Tacoma, Washington, United States, 98405
        • Available
        • Northwest Medical Specialties

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cogent Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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