Phase 1 Study of AST-201 to Assess Safety, Tolerability, and Drug Behavior in Adults with GPC3-Positive Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating AST-201, a new aptamer drug conjugate ApDC, in patients with GPC3-positive advanced solid tumors. This Phase 1 clinical study aims to assess the safety, tolerability, pharmacokinetics, and early signs of effectiveness of AST-201 across various tumor types, including hepatocellular carcinoma and non-small-cell lung carcinoma. The study is the first to test AST-201 in humans and is sponsored by Aptamer Sciences, Inc. The study has two parts Phase 1a involves gradually increasing doses of AST-201 given intravenously on Days 1, 8, and 15 of each 28-day cycle to find the highest safe dose and the recommended dose for further studies. In Phase 1b, patients receive the recommended dose to further evaluate safety and anti-tumor effects. Treatment continues until participants experience dose-limiting toxicity or disease progression. Participants will have regular assessments including safety monitoring, blood tests for drug levels, and tumor evaluations using RECIST criteria. The main outcome measured is the occurrence of dose-limiting toxicities within 4 weeks. Secondary outcomes include various pharmacokinetic parameters and tumor response rates assessed every 28 days for up to 6 months. The study involves ongoing safety follow-up and aims to support future development of AST-201 in this patient population.

A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors