Phase 1 Study of Oral Menin Inhibitor Ziftomenib Combined With Imatinib for Adults With Advanced Gastrointestinal Stromal Tumors After Imatinib Failure

What this Trial Is About

Researchers are studying adults with advanced or metastatic gastrointestinal stromal tumors GIST that have a KIT mutation and who have previously been treated with imatinib. The study aims to evaluate the safety, tolerability, and early antitumor effects of combining ziftomenib, an oral menin inhibitor, with imatinib, a kinase inhibitor. This Phase 1a1b trial focuses on patients who have experienced disease progression on imatinib. Participants will receive ziftomenib combined with imatinib in a non-randomized study design. The trial includes dose escalation, dose determination, and dose expansion phases to find the recommended dose and assess clinical benefit. Treatment cycles last 28 days, during which dosing and drug levels in the body will be closely monitored. This study does not use placebo or masking. Throughout the study, participants will undergo regular safety assessments, including monitoring of dose-limiting toxicities during the first 28-day cycle, adverse events, and tumor response over up to two years. Researchers will evaluate measures such as clinical benefit rate, overall response rate, progression-free survival, duration of response, and overall survival. Blood samples will be collected to study how the drugs behave in the body. Participants will also be monitored for heart function and other health indicators to ensure safety during the trial.

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)