A Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.