Phase I Randomized Study of Ipilimumab Biosimilar HLX13 Versus US-Sourced YERVOY Evaluating Safety, Effectiveness, and Pharmacokinetics in First-Line Treatment of Unresectable Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the pharmacokinetic profile, safety, efficacy, and immunogenicity of HLX13, an ipilimumab biosimilar, compared to the US-sourced YERVOY in adults with unresectable hepatocellular carcinoma HCC who have not previously received systemic therapy. This phase I, multicenter, randomized, double-blind study aims to understand how these treatments behave in the body and their effects on this advanced liver cancer. Participants will be randomly assigned to receive either HLX13 or US-sourced YERVOY at a dose of 3 mgkg on the first day of each 3-week cycle, for up to four cycles. Additionally, all subjects will receive EU-sourced OPDIVO nivolumab at 1 mgkg on the first day of each 3-week cycle for four cycles. Those who benefit from OPDIVO treatment may continue with local-sourced OPDIVO every 4 weeks for up to two years after randomization. During the study, participants will undergo blood tests to measure drug concentrations and immune response at multiple points up to 20 weeks after the first dose. Safety will be closely monitored through physical exams, vital signs, laboratory tests, and heart monitoring for up to 13 weeks after dosing. Researchers will also assess tumor response and record any adverse events during treatment and a 90-day safety follow-up period. Overall, participants may be involved in the study for several months, with continued treatment and monitoring as appropriate.

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