Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/12/2025. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Open for enrollment

Contact information:

Steven Attia

attia.steven@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Thanh Ho, M.D.

Open for enrollment

Contact information:

Jordan Meyers

5072842030

meyers.jordan2@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Laura Patel

4805741569

patel.laura@mayo.edu

More information

Publications

Publications are currently not available