Phase II Study of HLX43 Drug for Advanced or Metastatic Liver Cancer After Standard Treatment Failure or Intolerance

What this Trial Is About

Researchers are evaluating HLX43, an anti-PD-L1 antibody-drug conjugate, in patients with locally advanced or metastatic hepatocellular carcinoma HCC who have failed or cannot tolerate standard treatments. This open-label phase II study aims to find the right dose and assess the drugs effectiveness, safety, and tolerability in this patient group. The trial is sponsored by Shanghai Henlius Biotech and includes adults aged 18 to 75 years. Participants will be randomly assigned to receive one of three different doses of HLX43 given by intravenous infusion every three weeks. Treatment continues until disease progression, unacceptable side effects, death, starting a new anti-cancer therapy, or withdrawal of consent. The drug combines an antibody targeting PD-L1 with a potent DNA topoisomerase I inhibitor. All groups receive the same schedule and monitoring during the study. During the study, participants undergo evaluations of tumor response using imaging based on RECIST v1.1 criteria, safety assessments, and laboratory tests. Researchers will measure objective response rate ORR up to 24 weeks and progression-free survival PFS up to 14 months. Secondary outcomes include overall survival and adverse event rates up to 36 and 24 months respectively. Participants are monitored regularly throughout treatment and follow-up until study completion or withdrawal.

A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy