Recruiting
Phase 1

Ziftomenib & Imatinib

Sponsor:

Kura Oncology, Inc.

Code:

NCT06655246

Conditions

Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Cancer

Gastrointestinal Stromal Neoplasm

Gastrointestinal Stromal Tumor, Malignant

Gastrointestinal Stromal Cell Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ziftomenib

imatinib mesylate

Study Details

Brief 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.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Cancer

Gastrointestinal Stromal Neoplasm

Gastrointestinal Stromal Tumor, Malignant

Gastrointestinal Stromal Cell Tumors

Study ID

NCT06655246

Start date

Mar 27, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

157 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Ziftomenib plus imatinib

experimental: Recommended Phase 2 Dose Determination

Ziftomenib plus imatinib

experimental: Dose Expansion

Ziftomenib plus imatinib

Interventions

ziftomenib

menin inhibitor

imatinib mesylate

kinase inhibitor

Primary outcome measure

  • Dose Escalation: Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 (first 28 day cycle) ]
  • Descriptive statistics of Adverse Events (AEs) [ Time Frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first ]
  • Dose Expansion: Clinical benefit rate (CBR) [ Time Frame: Up to 2 years following start of treatment with ziftomenib ]

Central Contacts and Locations

Central contacts

Kura Medical Information 844-KURAONC

844-587-2662medinfo@kuraoncology.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Mayo Clinic Cancer Center

Recruiting

Phoenix, Arizona, United States, 85054

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

University Of California, Irvine

Recruiting

Orange, California, United States, 92868

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

UCLA Santa Monica Medical Center

Recruiting

Santa Monica, California, United States, 90404

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Sarah Cannon Research Institute

Recruiting

Denver, Colorado, United States, 80220

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06511

Mayo Clinic Cancer Center

Recruiting

Jacksonville, Florida, United States, 32224

University of Miami

Recruiting

Miami, Florida, United States, 33136

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Harvard University

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic Cancer Center

Recruiting

Rochester, Minnesota, United States, 55905

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Temple University Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Sarah Cannon Research Institute

Recruiting

Dallas, Texas, United States, 75230

University of Texas

Recruiting

Houston, Texas, United States, 77030

University of Texas Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Kura Oncology, Inc.

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Cancer
  • Gastrointestinal Stromal Neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kura Oncology, Inc. on 2026-02-05.