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

Official record

Identifier

NCT07406633

Recruiting locations

country

United States

Interventions studied

KQB198Imatinib (Gleevec)

Lead sponsor

Kumquat Biosciences Inc.

Target enrolment

46 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Feb 12, 2026

Last updated on the registry

Aug 10, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Gastric Cancer