Phase I Study of HS387 Tablets Given Orally to Treat Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating HS387 in a Phase IaIb clinical trial to study its safety, tolerability, pharmacokinetics, and preliminary antitumor activity in adults with advanced solid tumors. The trial includes two parts a dose escalation phase Phase Ia to find the appropriate dose, followed by a dose expansion phase Phase Ib to further assess the treatment in more participants. The study is sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd. and focuses on participants who have limited treatment options for their cancer. Participants will receive HS387 tablets taken orally in the experimental group. The study begins with dose escalation to determine the best dose and proceeds to dose expansion to evaluate the treatment further. There is no placebo group, and the study is not blinded. The trial runs from July 2025 to December 2028. During the study, participants will undergo regular medical assessments including monitoring for adverse events and dose-limiting toxicities over a 2-year period. Researchers will measure safety outcomes such as the number of participants reporting side effects and serious adverse events. Participants tumor lesions will be evaluated by RECIST criteria, and their overall health and organ function will be monitored throughout the trial.

A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors