Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II study of HLX43, its antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. The drug, designed for advanced/metastatic solid tumors, has no comparable approved products globally.
Study Design
The Phase II trial will evaluate HLX43’s clinical efficacy in ESCC patients, with secondary endpoints including safety, pharmacokinetics, immunogenicity, and potential biomarkers. Participants will receive treatment every three weeks.
Drug Profile
HLX43 leverages Henlius’ ADC platform to deliver targeted therapy for PD-L1-expressing tumors. The study aims to establish its efficacy in ESCC, a high-unmet-need area with limited treatment options.
Strategic Outlook
The trial marks progress in Henlius’ oncology pipeline, focusing on innovative therapies for hard-to-treat cancers. If successful, HLX43 could become a key treatment for ESCC patients.-Fineline Info & Tech
