Status:
AVAILABLE
Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
Lead Sponsor:
Cogent Biosciences, Inc.
Conditions:
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06948955
Last Update
December 8 2025
Active Locations (7)
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1
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, United States, 90095
2
Orlando Health
Orlando, Florida, United States, 32806
3
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02215