Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-09; most recent amendment 2026-03-12.
Status change: Not Yet Recruiting → Recruiting 2026-03-12
Trial Details
NCT Number NCT07176650
Lead Sponsor Shanghai Henlius Biotech
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 246 participants
Start Date 2025-11-25
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-16