Evaluating Olverembatinib Treatment in SDH-Deficient Gastrointestinal Stromal Tumors After Prior Therapies

What this Trial Is About

Researchers are evaluating the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor GIST who have previously received at least one line of systemic therapy. This international phase III study aims to assess progression-free survival and clinical benefit rate of olverembatinib in this patient population. The study focuses on patients whose tumors show loss of SDHB expression and have measurable disease. Participants will take olverembatinib tablets orally at a dose of 40 mg every other day with meals. Each treatment cycle lasts 28 days, and dosing continues in cycles. The study is a single-arm trial, meaning all participants receive olverembatinib, with no placebo or comparison group. Participants must have failed at least one prior systemic therapy before starting this treatment. During the study, participants will be monitored for treatment response, including progression-free survival over 36 months. Blood samples will be taken to measure plasma concentrations of olverembatinib between cycles 2 and 3. Safety will be assessed by tracking treatment-related adverse events over an average of two years. Participants must complete study procedures, follow-up exams, and adhere to contraceptive requirements if applicable. The total study duration includes regular visits and assessments throughout treatment and follow-up periods.

A Study of Olverembatinib in SDH-deficient GIST.