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
Shanghai Henlius Biotech
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
Inclusion Criteria: 1. Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. 2. Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF. 3. Body weight: 50 kg-85 kg. 4. Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and/or locoregional therapies; or b) progressive disease after surgical and/or locoregional therapies. Subjects with only a radiologic diagnosis of hepatocellular carcinoma may…