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

NCT07406633 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: KQB198-103
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 16

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

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.

  30 months

Secondary Outcomes (9)

• Duration of response (DOR)

  30 months

• Disease control rate (DCR)

  30 months

• Time to response (TTR)

  30 months

• Progression-free survival (PFS)

  Up to 30 months

• Overall survival (OS)

  Up to 30 months

Study Arms (1)

KQB198 in Combination with Imatinib

EXPERIMENTAL

Drug: KQB198; Drug: Imatinib (Gleevec)

Interventions

KQB198 DRUG

Oral KQB198

KQB198 in Combination with Imatinib

Imatinib (Gleevec) DRUG

Oral Imatinib

KQB198 in Combination with Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kumquat Biosciences Inc.: lead

Study Sites (16)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Northwell Health/R.J. Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Digestive System Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Kumquat Clinical Development

CONTACT

858-214-2700; kumquatstudies@kumquatbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)