Phase I Study Evaluating Safety, Tolerability, and Pharmacokinetics of HLX37 in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting an open-label, first-in-human phase I clinical trial to assess the safety, tolerability, and pharmacokinetic PK characteristics of HLX37 in patients with advanced or metastatic solid tumors. The study focuses on patients who have not responded to standard treatments or have no effective standard options, including those with advanced non-small cell lung cancer NSCLC. This trial aims to carefully evaluate HLX37 dosing and effects to understand its potential in this patient population. The study has multiple parts. In Phase Ia Part 1, patients receive escalating doses of HLX37 through intravenous infusion using a 33 dose escalation design, with a dose-limiting toxicity DLT observation period of 3 weeks after the first dose. In Phase Ia Part 2, patients with advanced NSCLC receive HLX37 combined with chemotherapy at increasing doses every 3 weeks, also with a 3-week DLT observation. Phase Ib will expand dose groups based on safety, efficacy, and PK data from earlier phases. Overall, seven dose levels are planned, with patients receiving the recommended Phase 2 dose identified during escalation. Participants will undergo regular monitoring including safety assessments, pharmacokinetic sampling, and tumor evaluations based on RECIST 1.1 criteria. The primary outcomes include DLTs within 21 days post first dose and maximum tolerated dose determination. Secondary outcomes track response rates, duration of response, progression-free survival, overall survival, and maximum drug concentration up to 24 months. Patients must meet specific health and organ function criteria, agree to tumor tissue sampling, and will be monitored closely throughout the study period, which may last up to two years for outcome assessments.

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors