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KQB198 with Imatinib for Advanced GIST

This study is testing an experimental drug called KQB198 in combination with imatinib (Gleevec) for people with advanced or metastatic (spread to other parts of the body) Gastrointestinal Stromal Tumor (GIST). The main goal is to see how many participants respond to the treatment, measured over 30 months. To join, you must have GIST that cannot be removed by surgery or has spread, and your tumor tissue must show specific KIT or PDGFRA gene mutations (but not certain types). The study aims to find out if this drug combination is safe, tolerable, and effective. The status of this study is currently unclear.

Study design
This is an interventional study with a planned enrollment of 46 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, objective response rate, will be measured at 30 months.

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NCT07406633

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Kumquat Biosciences Inc.
~46 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:KQB198Imatinib (Gleevec)

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over 30 months

Conditions

GIST - Gastrointestinal Stromal Tumor
GIST
GIST Metastatic Cancer
Gastro Intestinal Stromal Tumour
Gastrointestinal Tumors

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

17 sites across 15 states
Florida3
California1
Illinois1
Iowa1
Massachusetts1
Michigan1
Minnesota1
New York1

Who to contact

Kumquat Clinical Development
[email protected]
858-214-2700
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.