NCT06742892

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

A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy

Detailed description

This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	HLX43 DOSE 1	Dose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUG	HLX43 DOSE 2	Dose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUG	HLX43 DOSE 3	Dose 3; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Timeline

• Start date: 2025-03-03
• Primary completion: 2026-10-31
• Completion: 2027-06-05
• First posted: 2024-12-19
• Last updated: 2025-03-10

Locations

1 site across 1 country: China