A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Condition(s) studied
Investigational drug(s) / intervention(s)
ziftomenib: menin inhibitor
imatinib mesylate: kinase inhibitor
Study 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 as current or prior therapy, or are treatment naive.
Eligibility
Primary outcome measure(s)
- Dose Limiting Toxicity (DLT) (Dose Expansion) — Cycle 1 (first 28 day cycle)
Rate of DLTs per dose level - Descriptive statistics of Adverse Events (AEs) — First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 - Clinical Benefit Rate (CBR) (Dose Escalation and Dose Expansion Cohorts A and B only) — Up to 2 years following start of treatment with ziftomenib
CBR is the rate of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed per Response Criteria in Solid Tumors (RECIST) v1.1 modified for GIST - Overall Response Rate (ORR) (Dose Expansion Cohort C) — Up to 2 years following start of treatment with ziftomenib
ORR is CR + PR assessed per RECIST v1.1 modified for GIST
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Mayo Clinic Cancer Center | Phoenix | Arizona | Recruiting |
| University of California, San Diego | La Jolla | California | Recruiting |
| University of Southern California | Los Angeles | California | Recruiting |
| University Of California, Irvine | Orange | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| UCLA Santa Monica Medical Center | Santa Monica | California | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | Recruiting |
| Sarah Cannon Research Institute | Denver | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Mayo Clinic Cancer Center | Jacksonville | Florida | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Harvard University | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Mayo Clinic Cancer Center | Rochester | Minnesota | Recruiting |
| Memorial Sloan-Kettering Cancer Center | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| Oregon Health & Science University | Portland | Oregon | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| Temple University Health System | Philadelphia | Pennsylvania | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Sarah Cannon Research Institute | Dallas | Texas | Recruiting |
| University of Texas | Houston | Texas | Recruiting |
| University of Texas Health Science Center | San Antonio | Texas | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More Kura Oncology, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06655246 on ClinicalTrials.gov ↗ ← All trials in the USA