Who is eligible for clinical trial NCT07406633?

Participants must meet protocol criteria for GIST - Gastrointestinal Stromal Tumor. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07406633 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-05

KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) (NCT07406633)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Kumquat Biosciences Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (4 items).

Location: USC Norris Comprehensive Cancer Center — Los Angeles, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗