KQB198 plus imatinib for first-line advanced or metastatic GIST
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
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Drugs / interventions | imatinib |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07406633 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Kumquat Clinical Development
- Email: kumquatstudies@kumquatbio.com
- Phone: 858-214-2700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.