Recruiting nowPhase 1Ages 18 Years and up

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Sponsor: Kura Oncology, Inc. · NCT06655246 on ClinicalTrials.gov ↗

Conditions studied

Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal CancerGastrointestinal Stromal NeoplasmGastrointestinal Stromal Tumor, MalignantGastrointestinal Stromal Cell Tumors

What it tests

ziftomenibdrug
imatinib mesylatedrug

Where it's running32 sites

University of Alabama at Birmingham
Birmingham, Alabama 35233
Recruiting now
Mayo Clinic Cancer Center
Phoenix, Arizona 85054
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University of California, San Diego
La Jolla, California 92093
Recruiting now
University of Southern California
Los Angeles, California 90033
Recruiting now
University Of California, Irvine
Orange, California 92868
Recruiting now
Stanford Cancer Institute
Palo Alto, California 94304
Recruiting now
UCLA Santa Monica Medical Center
Santa Monica, California 90404
Recruiting now
University of Colorado Cancer Center
Aurora, Colorado 80045
Recruiting now
Sarah Cannon Research Institute
Denver, Colorado 80220
Recruiting now
Yale University School of Medicine
New Haven, Connecticut 06511
Recruiting now
Mayo Clinic Cancer Center
Jacksonville, Florida 32224
Recruiting now
University of Miami
Miami, Florida 33136
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Northwestern University
Chicago, Illinois 60611
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University of Iowa
Iowa City, Iowa 52242
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Johns Hopkins University
Baltimore, Maryland 21287
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Massachusetts General Hospital
Boston, Massachusetts 02114
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Harvard University
Boston, Massachusetts 02215
Recruiting now
University of Michigan
Ann Arbor, Michigan 48109
Recruiting now
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
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Memorial Sloan-Kettering Cancer Center
New York, New York 10065
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Duke University Medical Center
Durham, North Carolina 27710
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Ohio State University
Columbus, Ohio 43210
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Oregon Health & Science University
Portland, Oregon 97239
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Thomas Jefferson University
Philadelphia, Pennsylvania 19107
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Temple University Health System
Philadelphia, Pennsylvania 19111
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Sarah Cannon Research Institute
Nashville, Tennessee 37203
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Vanderbilt University Medical Center
Nashville, Tennessee 37232
Recruiting now
Sarah Cannon Research Institute
Dallas, Texas 75230
Recruiting now
University of Texas
Houston, Texas 77030
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University of Texas Health Science Center
San Antonio, Texas 78229
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University of Utah
Salt Lake City, Utah 84112
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Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Recruiting now

See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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 intervention.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.

Key Exclusion Criteria:

* Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
* History of prior or current cancer that 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 before 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 before the first dose of study intervention.
* Is pregnant or breastfeeding.
* Gastrointestinal abnormalities that may impact taking study intervention by mouth.
* Actively bleeding, excluding hemorrhoidal or gum bleeding.

Updated 2026-02-05 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.