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
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 as current or prior therapy, or are treatment naive.
• Documented diagnosis of advanced/metastatic KIT-mutant GIST
• Documented disease progression on imatinib as current or prior therapy or is treatment naïve, as follows:
‣ DES: Participant is progressing or progressed on imatinib in any prior line of therapy.
⁃ EXP Cohort A: Participant is progressing or progressed on imatinib and has not received additional intervening therapy before study participation.
⁃ EXP Cohort B: Participant has progressed on imatinib and sunitinib only and has not received additional intervening therapy before study participation.
⁃ EXP Cohort C: Participant has newly diagnosed advanced/metastatic GIST and is treatment naïve in the advanced/metastatic setting.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.
• At least 1 measurable lesion per RECIST v1.1 modified for GIST.
• Negative pregnancy test for participants of childbearing potential.
• Adequate organ function per protocol requirements.
• Resolution of all clinically significant toxicities from prior therapy to \<Grade 1 (or participant baseline) within 1 week before the first dose of study intervention.
• Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.