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

Available (expanded access)

Conditions studied: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

In brief

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.

Key facts

Study ID

NCT06948955

Run by

Cogent Biosciences, Inc.

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Department of Medicine- Hematology/Oncology — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Smillow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dana Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Taylor Cancer Research Center — Maumee, Ohio, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States
• Shenandoah Oncology — Winchester, Virginia, United States
• Shenandoah Oncology — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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