NCT07176650

Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	HLX13	Patients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
DRUG	Yervoy	Patients will receive US-sourced YERVOY® (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
DRUG	OPDIVO	Patients will receive EU-sourced OPDIVO® (EU-sourced nivolumab) (1 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles. Subjects who may continue to benefit from OPDIVO® treatment as assessed by investigators will be subsequently treated with local-sourced OPDIVO® monotherapy every 4 weeks, up to 2 year after randomization.

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-09-16
• Last updated: 2026-03-16

Locations

51 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study