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

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.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

No

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.

Locations (51)