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Clinical trial

A Randomized, Multicenter, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY® and EU-Sourced YERVOY®) As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

NCT06841185 is registered in ClinicalTrials.gov with Shanghai Henlius Biotech as lead sponsor.

NCT NCT06841185
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Multicenter, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY® and EU-Sourced YERVOY®) As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma
Lead sponsor
Shanghai Henlius Biotech
Phase
Phase 3
Overall status
Not yet recruiting
Start date
April 30, 2025
Completion date
May 5, 2028
Enrollment
656 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

hepatocellular carcinoma (hcc)