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

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

  • Gastrointestinal Stromal Tumor (GIST)
  • Gastrointestinal Stromal Cancer
  • Gastrointestinal Stromal Neoplasm
  • Gastrointestinal Stromal Tumor, Malignant
  • Gastrointestinal Stromal Cell Tumors

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 4049979, Alabama 4829764 35233

Mayo Clinic Cancer Center
Phoenix 5308655, Arizona 5551752 85054

University of California, San Diego
La Jolla 5363943, California 5332921 92093

University of Southern California
Los Angeles 5368361, California 5332921 90033

University Of California, Irvine
Orange 5379513, California 5332921 92868

Stanford Cancer Institute
Palo Alto 5380748, California 5332921 94304

UCLA Santa Monica Medical Center
Santa Monica 5393212, California 5332921 90404

University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045

Sarah Cannon Research Institute
Denver 5419384, Colorado 5417618 80220

Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06511

Mayo Clinic Cancer Center
Jacksonville 4160021, Florida 4155751 32224

University of Miami
Miami 4164138, Florida 4155751 33136

Northwestern University
Chicago 4887398, Illinois 4896861 60611

University of Iowa
Iowa City 4862034, Iowa 4862182 52242

Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Harvard University
Boston 4930956, Massachusetts 6254926 02215

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Mayo Clinic Cancer Center
Rochester 5043473, Minnesota 5037779 55905

Memorial Sloan-Kettering Cancer Center
New York 5128581, New York 5128638 10065

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

Ohio State University
Columbus 4509177, Ohio 5165418 43210

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107

Temple University Health System
Philadelphia 4560349, Pennsylvania 6254927 19111

Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

Sarah Cannon Research Institute
Dallas 4684888, Texas 4736286 75230

University of Texas
Houston 4699066, Texas 4736286 77030

University of Texas Health Science Center
San Antonio 4726206, Texas 4736286 78229

University of Utah
Salt Lake City 5780993, Utah 5549030 84112

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

Status
Recruiting
Sponsor
Kura Oncology, Inc.

Study Contact

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