Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07406633
Recruiting Phase 2

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

NCT07406633 · tracked via the Priya Life Science USA tracker
Sponsor
Kumquat Biosciences Inc
Phase
Phase 2
Started
2026-06-23
Last updated
2026-08-10

Condition(s) studied

GIST - Gastrointestinal Stromal TumorGISTGIST Metastatic CancerGastro Intestinal Stromal TumourGastrointestinal Tumors

Investigational drug(s) / intervention(s)

KQB198 →Imatinib (Gleevec) →

KQB198: Oral KQB198

Imatinib (Gleevec): Oral Imatinib

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective response rate (ORR) — 30 months
    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.

Trial sites (17)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
University of Iowa Health Care Iowa City Iowa Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Hospitals Ann Arbor Michigan Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Northwell Health/R.J. Zuckerberg Cancer Center Lake Success New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
UT MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting

More Kumquat Biosciences Inc. trials in the USA

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Active, not recruiting
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies Active, not recruiting
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies Recruiting
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies Recruiting
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Recruiting

Other trials for the same condition

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib Active, not recruiting
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07406633 on ClinicalTrials.gov ↗ ← All trials in the USA