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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

imatinib mesylate. The mesylate salt of imatinib, a tyrosine kinase inhibitor with antineoplastic activity. Imatinib binds to an intracellular pocket located within tyrosine kinases (TK), thereby inhibiting ATP binding and preventing phosphorylation and the subsequent activation of growth receptors and their downstream signal transduction pathways. This agent inhibits TK encoded by the bcr-abl oncogene as well as receptor TKs encoded by the c-kit and platelet-derived growth factor receptor (PDGFR) oncogenes. Inhibition of the bcr-abl TK results in decreased proliferation and enhanced apoptosis in malignant cells of Philadelphia-positive (Ph+) hematological malignancies such as CML and ALL; effects on c-kit TK activity inhibit mast-cell and cellular proliferation in those diseases overexpressing c-kit, such as mastocytosis and gastrointestinal stromal tumor (GIST). NCI Drug Dictionary

Treatments listed in the registry

• KQB198 (Drug): Oral KQB198
• Imatinib (Gleevec) (Drug): Oral Imatinib

Na · Sequential · masking: None

Main goals

• Objective response rate (ORR) (30 months)

Other goals

• Duration of response (DOR)
• Disease control rate (DCR)
• Time to response (TTR)
• Progression-free survival (PFS)
• Overall survival (OS)
• Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)
• Area under the curve (AUC)
• Maximum plasma concentration (Cmax)
• Time to maximum plasma concentration (Tmax)

Planned enrollment: 46 (estimated).

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

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07406633
• NCI Drug Dictionary: C1687

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 9, 2026. Public record; not medical advice.