In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
Documented diagnosis of advanced/metastatic KIT-mutant GIST.
Documented disease progression on imatinib as current or prior therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.
At least 1 measurable lesion per RECIST v1.1 modified for GIST.
Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
History of prior or current cancer that 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 before the first dose of study intervention.
Active central nervous system metastases.