A Phase III Trial to Assess Safety and Effects of ICP-723 in Patients 12 Years and Older With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a multicenter, nonrandomized, open-label Phase III clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ICP-723 in patients with solid tumors. The study focuses on patients with surgically unresectable locally advanced or metastatic solid tumors, including primary central nervous system tumors. This trial aims to better understand how ICP-723 behaves in the body and its safety profile during treatment. Participants will receive ICP-723, a white, round, uncoated tablet, as the investigational drug. The study includes adolescent participants aged 12 to under 18 years and adults aged 18 years and older. The trial involves monitoring treatment-emergent adverse events for up to 12 months and determining the maximum tolerated dose within the first two months. Secondary measures include peak drug concentration and objective response rate within specified time frames. During the study, participants will undergo evaluations of safety and tolerability, including assessments of adverse events and pharmacokinetic measurements. Measurable tumor lesions will be monitored according to established criteria. Patients will need to agree to use effective birth control methods if of childbearing potential and comply with visit schedules and treatment regimens. The total participation period includes follow-up for safety and treatment response, with data collected up to 12 months.

A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors