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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Hepatocellular Carcinoma (HCC)
Interventions
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.

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY