Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
1 other identifier
expanded_access
N/A
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedApril 2, 2026
April 1, 2026
March 31, 2025
April 1, 2026
Conditions
Keywords
Interventions
Drug: Bezuclastinib
Drug: Sunitinib (locally sourced)
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, 90095, United States
University of Colorado
Aurora, Colorado, 80045, United States
Smillow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Orlando Health
Orlando, Florida, 32806, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rachael Easton, MD, PhD
Cogent Biosciences, Inc.
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 29, 2025
Last Updated
April 2, 2026
Record last verified: 2026-04