Actively Recruiting
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
Led by Kura Oncology, Inc. · Updated on 2026-02-05
157
Participants Needed
32
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 1a/1b 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.
CONDITIONS
Brief Title
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of advanced or metastatic KIT-mutant gastrointestinal stromal tumor (GIST)
- Documented disease progression on imatinib as current or prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening
- At least one measurable lesion per RECIST v1.1 modified for GIST
- Negative pregnancy test for participants who can become pregnant
- Adequate organ function as specified in the study protocol
- Resolution of all significant toxicities from prior therapies to less than Grade 1 or baseline within one week before first dose
- Ability to understand and provide written informed consent before screening
You will not qualify if you...
- Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation
- History of prior or current cancer that may interfere with study results
- Use of prohibited medications, including investigational therapy, within 14 days or five drug half-lives before first dose
- Active central nervous system metastases
- Uncontrolled illnesses including specified cardiac disease
- Mean corrected QT interval (QTcF) greater than 470 ms
- Left ventricular ejection fraction less than 50%
- Major surgery within two weeks before first dose
- Pregnant or breastfeeding
- Gastrointestinal conditions affecting oral medication intake
- Active bleeding excluding hemorrhoidal or gum bleeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive the oral menin inhibitor ziftomenib in combination with imatinib to treat advanced gastrointestinal stromal tumors (GIST).
Visits on Day 1 of each 28-day cycle for assessments
Duration - Up to 2 years following start of treatment
Participants are monitored for safety and clinical benefit after treatment ends, up to 2 years from the start of treatment.
Approximately 6 to 8 visits over 2 years
Trial Site Locations
Total: 32 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
4
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
5
University Of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
6
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
7
UCLA Santa Monica Medical Center
Santa Monica, California, United States, 90404
Actively Recruiting
8
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Sarah Cannon Research Institute
Denver, Colorado, United States, 80220
Actively Recruiting
10
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
11
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
12
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
13
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
14
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Harvard University
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
19
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
21
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
23
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
24
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
25
Temple University Health System
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
26
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
Sarah Cannon Research Institute
Dallas, Texas, United States, 75230
Actively Recruiting
29
University of Texas
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
31
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
32
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
K
Kura Medical Information 844-KURAONC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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