HENLIUS (02696) announced that the first patient in China has been dosed in its international multicenter Phase 1 clinical study for HLX13 (recombinant fully human anti-CTLA-4 monoclonal antibody injection), a biosimilar of ipilimumab, as a first-line treatment for unresectable hepatocellular carcinoma (HCC).

The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial designed to evaluate the pharmacokinetic (PK) profile, safety, efficacy, and immunogenicity similarity between HLX13 and its reference drug YERVOY® (U.S. marketed version), each in combination with OPDIVO® (EU marketed version, generic name: nivolumab), in previously untreated patients with unresectable advanced HCC.

Eligible participants will be randomized in a 1:1 ratio into two groups. During the first four cycles, patients will receive either HLX13 or YERVOY® in combination with OPDIVO® every three weeks, followed by OPDIVO® monotherapy every four weeks as maintenance treatment.

The primary endpoints include the area under the serum concentration-time curve (AUC0-21d) from pre-dose to 21 days after the first dose and the steady-state AUC (AUCss) within the dosing interval after the fourth dose. Secondary endpoints consist of additional PK parameters, efficacy assessments, safety, and immunogenicity.