Phase 1 and 2 Open-Label Study of Oral ICP-723 for Treating Advanced Solid Tumors or Primary Central Nervous System Tumors with NTRK Fusion

What this Trial Is About

Researchers are evaluating ICP-723 in patients with advanced solid tumors or primary central nervous system CNS tumors that have NTRK gene fusions. This open-label, multi-center Phase 2 basket clinical trial aims to assess ICP-723s effects in people who have not previously received NTRK inhibitor treatment. The study focuses on patients with measurable tumors and good performance status to better understand treatment responses and safety. Participants receive ICP-723 tablets orally once a day, with each treatment cycle lasting 28 days. This is a non-randomized study without a placebo group, and all participants are given the study drug. The trial spans an average of four years during which researchers monitor tumor responses and other health outcomes. Throughout the study, participants undergo regular evaluations including tumor measurements using RECIST, RANO, or INRC criteria, depending on tumor type. Safety is closely monitored by assessing adverse events and heart function. Researchers also measure drug levels in the blood and track survival and disease progression. The total study duration allows for long-term follow-up of effectiveness and side effects.

Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors