Clinical Trials

Key Inclusion Criteria:

* Documented diagnosis of advanced or metastatic KIT mutant GIST.
* Documented disease progression on imatinib therapy as current or prior treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
* At least 1 measurable lesion per mRECIST.
* Negative pregnancy test for female patients of childbearing potential.
* Adequate organ function per protocol requirements.
* Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.

Key Exclusion Criteria:

* Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST.
* History of prior or currently has cancer which has potential to interfere with obtaining study results.
* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives prior to the first dose of study intervention.
* Active central nervous system metastases.
* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Mean corrected QT interval (QTcF) greater than 470ms. * Left ventricular ejection fraction (LVEF) \<50%.
* Major surgery within 2 weeks prior to the first dose of study intervention.
* Is pregnant or lactating.
* Gastrointestinal abnormalities that may impact taking study intervention by mouth.
* Actively bleeding, excluding hemorrhoidal or gum bleeding.

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

Eligibility last updated 11/04/2024. Questions regarding updates should be directed to the study team contact.