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A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06655246•Kura Oncology, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.
+1 more criteria

Locations (32)

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

University Of California, Irvine

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

UCLA Santa Monica Medical Center

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Sarah Cannon Research Institute

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Key Dates

Start Date

March 27, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

February 5, 2026

Enrollment

157

ESTIMATED participants

Conditions

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

Interventions

ziftomenib

DRUG

imatinib mesylate

DRUG

Contacts

Kura Medical Information 844-KURAONC

CONTACT

844-587-2662 medinfo@kuraoncology.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery

B-Receptor Signaling in Cardiomyopathy

A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene