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NCT07406633PHASE2Recruiting

KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)

Kumquat Biosciences Inc.

Start Date

6/1/2026

Completion Date

10/1/2028

Summary

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria All Participants: * Unresectable or metastatic disease * Tissue confirmation of GIST * Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V). * Measurable disease per RECIST v1.1. * Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago. * Adequate organ function and performance status Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: * Unable to swallow or GI condition that prevents absorption. * Other active malignancies within the last 2 years. * History of hypersensitivity to any component of KQB198 or imatinib.

Interventions

DRUG

KQB198

DRUG

Imatinib (Gleevec)

Interested in This Trial?

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Conditions

GIST - Gastrointestinal Stromal TumorGISTGIST Metastatic CancerGastro Intestinal Stromal TumourGastrointestinal Tumors

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida 32224

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Iowa Health Care

Iowa City, Iowa 52242

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

University of Michigan Hospitals

Ann Arbor, Michigan 48109

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Northwell Health/R.J. Zuckerberg Cancer Center

Lake Success, New York 11042

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

UT MD Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States