Recruiting
Phase 2

KQB198 & Imatinib

Sponsor:

Kumquat Biosciences Inc.

Code:

NCT07406633

Conditions

GIST - Gastrointestinal Stromal Tumor

GIST

GIST Metastatic Cancer

Gastro Intestinal Stromal Tumour

Gastrointestinal Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KQB198

Imatinib (Gleevec)

Study Details

Brief 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.

Conditions

GIST - Gastrointestinal Stromal Tumor

GIST

GIST Metastatic Cancer

Gastro Intestinal Stromal Tumour

Gastrointestinal Tumors

Study ID

NCT07406633

Start date

Jun 23, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KQB198 in Combination with Imatinib

Interventions

KQB198

Oral KQB198

Imatinib (Gleevec)

Oral Imatinib

Primary outcome measure

  • Objective response rate (ORR) [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Kumquat Clinical Development

858-214-2700kumquatstudies@kumquatbio.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Mayo Clinic - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan Hospitals

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Northwell Health/R.J. Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Kumquat Biosciences Inc.

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

  • KQB198
  • imatinib
  • gleevec
  • gist
  • gastrointestinal stromal tumor
  • gastro intestinal stromal tumor
  • gist first line
  • gist 1st line
  • KQB198-103
  • SynerGIST
  • SynerGIST-1
  • SynerGIST-1st
  • SynerGIST-1st Line

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kumquat Biosciences Inc. on 2026-08-10.