A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Phase 3 Not yet recruiting 656 enrolled Shanghai Henlius Biotech

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, and immunogenicity of HLX13 and YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Timeline

Start: 2025-04-30
Primary completion: 2027-06-06
Completion: 2028-05-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX13	Monoclonal antibody	3 mg/kg	—
Comparator	Ipilimumab	Monoclonal antibody	3 mg/kg	—
Background	Nivolumab	Monoclonal antibody	1 mg/kg	—

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Summary

Timeline

Drugs

Indications