Phase III Study to Assess Safety, Tolerability, and Antitumor Effects of ALK201 in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating ALK201, an investigational drug, in adults with advanced solid tumors to assess its safety, tolerability, how the body processes it, and its potential antitumor effects. This first-in-human, open-label study aims to find the best dose for future research. The study is sponsored by Shanghai Allink Biotherapeutics Co., Ltd. and includes adults aged between 18 and 75 years with measurable tumors and good overall health status. The study has two parts Part A is a dose-escalation phase to determine the maximum tolerated dose and the doses for further study, while Part B is a dose-expansion phase enrolling selected patient groups. ALK201 is given intravenously once every three weeks. The study will monitor participants closely during and after treatment to understand the drugs effects and safety profile. Participants will undergo various evaluations including tumor measurements, laboratory tests, and assessments of organ function and immune response over approximately 36 months. Researchers will also track pharmacokinetics and biomarkers to evaluate treatment impact. Safety and tolerability will be assessed continuously, and participants will be followed to observe preliminary antitumor activity and immunogenicity.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors