智通财经APP讯，复宏汉霖(02696)发布公告，近日，公司自主研发的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。
本研究为一项国际多中心、随机、双盲、平行对照1期临床研究，旨在评价 HLX13或其原研药YERVOY® (美国市售)分别联合OPDIVO® (欧盟市售，通用名：纳武利尤单抗)，在既往未经治疗的不可切除的晚期肝细胞癌(HCC)患者中的药代动力学(PK)特征、安全性、疗效和免疫原性的相似性。合格的受试者将按1:1的比例随机分配至两组，在前4个周期，受试者每3周接受一次 HLX13或YERVOY®联合OPDIVO®治疗，随后每4周接受一次OPDIVO®单药维持治疗。主要终点为从给药前至首次给药后21天的血药浓度-时间曲线下面积(AUC0-21d)和第4次给药后稳态给药间隔内血药浓度-时间曲线下面积 (AUCss)。次要终点包括其他PK参数、有效性评估、安全性及免疫原性。
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