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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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. - Actively bleeding, excluding hemorrhoidal or gum bleeding.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Ziftomenib plus imatinib
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec
Experimental
Recommended Phase 2 Dose Determination 		Ziftomenib plus imatinib
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec
Experimental
Dose Expansion 		Ziftomenib plus imatinib
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233

Mayo Clinic Cancer Center
Phoenix, Arizona 85054

University of California, San Diego
La Jolla, California 92093

University of Southern California
Los Angeles, California 90033

University Of California, Irvine
Orange, California 92868

Stanford Cancer Institute
Palo Alto, California 94304

UCLA Santa Monica Medical Center
Santa Monica, California 90404

University of Colorado Cancer Center
Aurora, Colorado 80045

Sarah Cannon Research Institute
Denver, Colorado 80220

Yale University School of Medicine
New Haven, Connecticut 06511

Mayo Clinic Cancer Center
Jacksonville, Florida 32224

University of Miami
Miami, Florida 33136

Northwestern University
Chicago, Illinois 60611

University of Iowa
Iowa City, Iowa 52242

Johns Hopkins University
Baltimore, Maryland 21287

Massachusetts General Hospital
Boston, Massachusetts 02114

Harvard University
Boston, Massachusetts 02215

University of Michigan
Ann Arbor, Michigan 48109

Mayo Clinic Cancer Center
Rochester, Minnesota 55905

Memorial Sloan-Kettering Cancer Center
New York, New York 10065

Duke University Medical Center
Durham, North Carolina 27710

Ohio State University
Columbus, Ohio 43210

Oregon Health & Science University
Portland, Oregon 97239

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Temple University Health System
Philadelphia, Pennsylvania 19111

Sarah Cannon Research Institute
Nashville, Tennessee 37203

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Sarah Cannon Research Institute
Dallas, Texas 75230

University of Texas
Houston, Texas 77030

University of Texas Health Science Center
San Antonio, Texas 78229

University of Utah
Salt Lake City, Utah 84112

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT06655246
Status
Recruiting
Sponsor
Kura Oncology, Inc.

Study Contact

Kura Medical Information 844-KURAONC
844-587-2662
medinfo@kuraoncology.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center