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.
Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
Body weight: 50 kg-85 kg.
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 be enrolled for screening in the study but histological confirmation is mandatory prior to randomization.
With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
Other malignancies active within 3 years prior to or at screening except for localized tumors that have been cured such as basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study.
History of hepatic encephalopathy prior to screening.
Parallel
HLX13
DrugPatients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
Yervoy
DrugPatients will receive US-sourced YERVOY® (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
OPDIVO
DrugPatients 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.
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 4th dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Maximum serum drug concentration (Cmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Maximum serum drug concentration at steady-state (Cmax,ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Trough serum drug concentration (Ctrough)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Trough serum drug concentration at steady-state (Ctrough,ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
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