Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a Phase 1 clinical trial for its self-developed biosimilar HLX13, targeting unresectable hepatocellular carcinoma (HCC) patients in China [1] Group 1: Clinical Trial Details - The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial [1] - The trial aims to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity similarities between HLX13 and its reference drug YERVOY® when combined with OPDIVO® in previously untreated advanced HCC patients [1] - Eligible participants will be randomly assigned in a 1:1 ratio to receive either HLX13 or YERVOY® combined with OPDIVO® for the first four cycles, followed by OPDIVO® monotherapy for maintenance treatment every four weeks [1] Group 2: Study Endpoints - The primary endpoint includes the area under the concentration-time curve (AUC0-21d) from pre-dosing to 21 days post-first dosing and the steady-state AUC during the dosing interval after the fourth administration [1] - Secondary endpoints encompass other PK parameters, efficacy assessments, safety, and immunogenicity evaluations [1]
复宏汉霖(02696)：伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆抗体注射液)一线治疗不可切除的肝细胞癌(HCC)患者的国际多中心1期临床研究于中国境内完成首例患者给药