Shanghai Henlius Biotech, Inc. (HENLIUS) has initiated patient dosing in a first-in-human Phase 1 clinical study of HLX48, an antibody–drug conjugate (ADC) that simultaneously targets EGFR and c-MET, for the treatment of advanced or metastatic solid tumors in Mainland China. Subject to regulatory conditions, a parallel study is planned in Australia.
The open-label, dose-escalation trial will evaluate six intravenous dose cohorts ranging from 1.5 mg/kg to 15 mg/kg administered every three weeks. After each cohort completes dosing and a 21-day safety observation, a Safety Review Committee will determine escalation to the next dose level.
Primary objective • Establish the maximum tolerated dose based on the incidence of dose-limiting toxicities.
Secondary objectives • Assess overall safety profile, pharmacokinetics, immunogenicity, objective response rate, progression-free survival and overall survival.
HLX48 combines a bispecific antibody against c-MET and EGFR with a cytotoxic payload. The construct is designed to induce receptor-mediated endocytosis, deliver the payload to tumor cells, block EGF/HGF ligand binding and activate antibody-dependent cell-mediated cytotoxicity, aiming for synergistic anti-tumor activity with a favorable safety profile. Pre-clinical studies demonstrated promising efficacy and tolerability.
Regulatory milestones include approval of the Phase 1 protocol by China’s National Medical Products Administration and acknowledgement by Australia’s Therapeutic Goods Administration. Currently, no bispecific ADC targeting both EGFR and c-MET has received marketing authorization worldwide.
Management emphasizes that successful development and commercialization of HLX48 remain subject to clinical outcomes and regulatory review. Shareholders and potential investors are advised to exercise caution when dealing in HENLIUS shares.
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