Phase 1 Study of Ziftomenib in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
To evaluate survival and disease control outcomes of ziftomenib in combination with imatinib in advanced/metastatic GIST patients who are progressing or progressed on imatinib.
Why this Research Matters
This is a Phase 1 dose escalation, recommended Phase 2 dose (RP2D) determination and expansion study to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of ziftomenib in combination with imatinib. Ziftomenib dose levels will be investigated in combination with 400 mg imatinib to identify a RP2D of the combination that will be further evaluated in the dose expansion part of the study.
Who can Participate
Inclusion: -Documented biopsy-proven diagnosis of advanced or metastatic KIT mutant GIST. -Documented disease progression on imatinib therapy as current or prior treatment Exclusion: -Known active central nervous system metastases. -Left ventricular ejection fraction (LVEF) <50% at screening. Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 25-0466
More information available at ClinicalTrials.gov: NCT06655246
Meet the Team
Principal Investigator