A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
NCT ID: NCT06655246
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
157 participants
INTERVENTIONAL
2025-03-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
ziftomenib
menin inhibitor
imatinib mesylate
kinase inhibitor
Recommended Phase 2 Dose Determination
ziftomenib
menin inhibitor
imatinib mesylate
kinase inhibitor
Dose Expansion
ziftomenib
menin inhibitor
imatinib mesylate
kinase inhibitor
Interventions
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ziftomenib
menin inhibitor
imatinib mesylate
kinase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented disease progression on imatinib therapy as current or prior treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
* At least 1 measurable lesion per mRECIST.
* Negative pregnancy test for female patients of childbearing potential.
* Adequate organ function per protocol requirements.
* Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Exclusion Criteria
* History of prior or currently has cancer which has potential to interfere with obtaining study results.
* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives prior to the first dose of study intervention.
* Active central nervous system metastases.
* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Mean corrected QT interval (QTcF) greater than 470ms.
* Left ventricular ejection fraction (LVEF) \<50%.
* Major surgery within 2 weeks prior to the first dose of study intervention.
* Is pregnant or lactating.
* Gastrointestinal abnormalities that may impact taking study intervention by mouth.
* Actively bleeding, excluding hemorrhoidal or gum bleeding.
18 Years
ALL
No
Sponsors
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Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
UCLA Santa Monica Medical Center
Santa Monica, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Harvard University
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Health System
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sarah Cannon Research Institute
Dallas, Texas, United States
University of Texas
Houston, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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KO-MEN-015
Identifier Type: -
Identifier Source: org_study_id