KQB198 plus imatinib for first-line advanced or metastatic GIST
Official title: A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GI Stromal Tumor in 1st Line Setting
Run by Kumquat Biosciences Inc. · NCT07406633 · Data updated 2026-11-12
This Phase 2 test will see if adding the experimental drug KQB198 to imatinib helps people with advanced or metastatic GIST who are starting first-line treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Drugs / interventions | imatinib |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2028 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07406633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with unresectable or metastatic, KIT- or PDGFRA-mutant GIST (excluding KIT exon 9 and PDGFRA D842V), measurable disease, and who are starting first-line treatment are ideal candidates.
✕Probably not a fit
Patients with KIT exon 9 or PDGFRA D842V mutations, recent other active cancers, an inability to absorb oral medications, or known hypersensitivity to KQB198 or imatinib are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial gives KQB198 together with standard imatinib to adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) in the first-line setting. Participants must have a KIT or PDGFRA mutation (excluding KIT exon 9 and PDGFRA D842V) and measurable disease by RECIST v1.1. The study will monitor safety, tolerability, and signs of clinical activity while patients take both oral agents. Prior adjuvant or neoadjuvant imatinib is allowed if it was stopped more than one year before enrollment.
Why it matters
Potential benefit: If successful, the combination could improve tumor control and extend progression-free survival compared with imatinib alone.
How similar studies have gone: Imatinib is an established effective first-line therapy for GIST, but combining it with novel agents like KQB198 is a newer approach with limited published human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States Recruiting -
Sylvester Comprehensive Cancer Center
Miami, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
University of Chicago Medical Center
Chicago, Illinois, United States Recruiting -
University of Iowa Health Care
Iowa City, Iowa, United States Recruiting
Show 11 more locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
University of Michigan Hospitals
Ann Arbor, Michigan, United States Recruiting -
Mayo Clinic - Rochester
Rochester, Minnesota, United States Recruiting -
Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York, United States Recruiting -
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Recruiting -
UT MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Huntsman Cancer Institute
Salt Lake City, Utah, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Kumquat Clinical Development
- Email: kumquatstudies@kumquatbio.com
- Phone: 858-214-2700
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This registry collects medical information from people with GIST to see how the disease behaves in real life and to help improve care.
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Velzatinib for advanced GIST after multiple prior TKIs
This study tests velzatinib to see if it can shrink or slow tumors in people with metastatic or unresectable GIST who have progressed on or could not tolerate standard therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.