Actively Recruiting
Phase 2 Study Evaluating Oral KQB198 Combined with Imatinib for Advanced or Metastatic Gastrointestinal Stromal Tumor in First-Line Treatment
Led by Kumquat Biosciences Inc. · Updated on 2026-08-10
46
Participants Needed
17
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of an experimental drug called KQB198 with imatinib for treating advanced or metastatic Gastrointestinal Stromal Tumor GIST in patients receiving first-line treatment. The study aims to assess the safety, tolerability, and effectiveness of this combination. Imatinib is an FDA-approved treatment for various cancers including GIST, and this trial explores if adding KQB198 improves outcomes. Participants will receive oral KQB198 together with oral imatinib as part of the treatment. This Phase 2 study follows a sequential design to monitor responses and adverse effects over time. The treatment duration and dosing schedules are designed to evaluate how well the combination controls tumor growth and affects patient health. Throughout the study, participants will undergo assessments to measure tumor response using standardized criteria, monitor treatment side effects, and evaluate survival outcomes over up to 30 months. Blood and tumor tissue testing will be used to confirm eligibility and monitor biomarkers. Safety monitoring includes tracking adverse events and dose-limiting toxicities. Participants remain under medical supervision during the trial period, which concludes by October 2028.
CONDITIONS
Brief Title
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
Research Team
K
Kumquat Clinical Development
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