Zhitong Finance App News, Fu Hong Han Lin (02696) issued an announcement. Recently, a phase 1 clinical study of injectable HLX42 (targeted EGFR antibody-novel DNA topoisomerase I inhibitor conjugate drug) (HLX42) in patients with advanced/metastatic solid tumors completed the first patient administration in mainland China.
This study is the first phase 1 human clinical study to evaluate the safety, tolerability, and dose escalation of HLX42 in patients with advanced/metastatic solid tumors. The study will use a “3+3” dose escalation method. Patients will receive HLX42 intravenous infusion every three weeks at 7 different dosage levels (0.1 mg/kg, 0.3 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, and 4.0 mg/kg). The observation period for dose-limiting toxicity (DLT) was three weeks after initial administration of HLX42. The main endpoints of this study were the proportion of patients with DLT events in each dose group and the maximum tolerated dose (MTD) of HLX42 during the DLT observation period; secondary endpoints included safety, pharmacokinetic parameters, immunogenicity, initial efficacy, pharmacodynamic indicators, and potential predictive and drug resistance biomarkers.