Phase II Study of HLX43 Drug for Adults With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Who Did Not Respond to or Could Not Tolerate Standard First-Line Treatment

What this Trial Is About

Researchers are evaluating HLX43, an investigational drug, in patients with recurrent or metastatic esophageal squamous cell carcinoma ESCC who have not responded to or cannot tolerate standard first-line treatments. This open-label phase II study aims to determine the appropriate dose and assess the drugs effectiveness, safety, and tolerability in this patient population. The study is sponsored by Shanghai Henlius Biotech. Participants will be randomly assigned to one of four groups receiving different doses of HLX43 via intravenous infusion every three weeks. The doses under study include 2.0 mgkg, 2.5 mgkg, 3.0 mgkg, and a 3.0 mgkg loading dose. This dosing schedule will continue to evaluate the best dose for further research. Throughout the study, participants will undergo various assessments including tumor measurements based on RECIST v1.1 criteria, laboratory tests to monitor organ function, and evaluations for side effects. The primary outcomes focus on objective response rate within 24 weeks and progression-free survival up to 14 months. Secondary measures include overall survival and the incidence of adverse events observed up to 24 months. Participants will be monitored regularly during treatment and follow-up to understand the drugs impact and safety over time.

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy