Phase 12 Study of Inlexisertib Combined With Other Cancer Treatments in Adults With Advanced Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are studying the combination of inlexisertib with other anticancer therapies in adults with advanced malignancies, focusing on participants with gastrointestinal stromal tumors GIST. This Phase 12 open-label study aims to evaluate the safety, dosage, and preliminary effectiveness of these combinations across different modules defined by specific drug pairings. The study is sponsored by Deciphera Pharmaceuticals, LLC and involves multiple centers. Participants will receive inlexisertib tablets combined with ripretinib in 28-day treatment cycles. The study includes a dose escalation phase to determine safe dosing and an expansion phase to evaluate preliminary efficacy in patients with second-line advanced GIST. The study modules are organized sequentially, with some modules already closed without enrollment and others actively recruiting. During the study, participants will undergo regular assessments including laboratory tests to monitor organ function and bone marrow reserve, tumor biopsies when possible, and imaging to measure tumor response. Researchers will track adverse events, dosing recommendations, and tumor response rates over approximately 24 months, with additional monitoring of survival and drug concentrations. Participants may be involved for up to several years, with safety and treatment effectiveness continually evaluated.

A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies