HENLIUS (02696) announced that an international multicenter Phase 2 clinical study of injectable HLX43 (PD-L1 targeted antibody-drug conjugate) in patients with advanced non-small cell lung cancer (NSCLC) has completed the first patient dosing in the United States.

The Phase 2 clinical study is also being conducted simultaneously in mainland China (excluding Hong Kong, Macau, and Taiwan). The company plans to initiate clinical trials in Australia, Japan, and other countries when conditions permit.

This study is an open-label, international multicenter Phase 2 clinical trial designed to evaluate the efficacy and safety of HLX43 in patients with advanced non-small cell lung cancer (NSCLC). The research is divided into two stages: the first stage will conduct dose exploration to select an appropriate HLX43 dose for the second stage study; the second stage is a single-arm, multicenter Phase 2 clinical study.

The primary objective of this study is to evaluate the clinical efficacy of HLX43 in advanced non-small cell lung cancer (NSCLC). The primary endpoint is the objective response rate as assessed by a blinded independent central review committee according to RECIST v1.1 criteria.

HLX43 is a PD-L1 targeted antibody-drug conjugate. As of the announcement date, no PD-L1 targeted antibody-drug conjugate has been approved for marketing globally.