Back to Trials
NCT06655246PHASE1Recruiting

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

Kura Oncology, Inc.

Start Date

3/27/2025

Completion Date

12/1/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

ziftomenib

DRUG

imatinib mesylate

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

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

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Mayo Clinic Cancer Center

Phoenix, Arizona 85054

United States

University of California, San Diego

La Jolla, California 92093

United States

University of Southern California

Los Angeles, California 90033

United States

University Of California, Irvine

Orange, California 92868

United States

Stanford Cancer Institute

Palo Alto, California 94304

United States

UCLA Santa Monica Medical Center

Santa Monica, California 90404

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

Sarah Cannon Research Institute

Denver, Colorado 80220

United States

Yale University School of Medicine

New Haven, Connecticut 06511

United States

Mayo Clinic Cancer Center

Jacksonville, Florida 32224

United States

University of Miami

Miami, Florida 33136

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Iowa

Iowa City, Iowa 52242

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Harvard University

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Mayo Clinic Cancer Center

Rochester, Minnesota 55905

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Ohio State University

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Temple University Health System

Philadelphia, Pennsylvania 19111

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Sarah Cannon Research Institute

Dallas, Texas 75230

United States

University of Texas

Houston, Texas 77030

United States

University of Texas Health Science Center

San Antonio, Texas 78229

United States

University of Utah

Salt Lake City, Utah 84112

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States