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
Kura Oncology, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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. * 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 intervent…
Interventions
- Drugziftomenib
menin inhibitor
- Drugimatinib mesylate
kinase inhibitor
Locations (32)
- University of Alabama at BirminghamBirmingham, Alabama
- Mayo Clinic Cancer CenterPhoenix, Arizona
- University of California, San DiegoLa Jolla, California
- University of Southern CaliforniaLos Angeles, California
- University Of California, IrvineOrange, California
- Stanford Cancer InstitutePalo Alto, California