智通财经APP讯，复宏汉霖(02696)公布，近日，一项注射用HLX43(靶向PD-L1 抗体-新型DNA拓扑异构酶I抑制剂偶联药物)(HLX43)在复发/转移性食管鳞癌患者中开展的2期临床研究于中国境内(不包括中国港澳台地区，下同)完成首例患者给药。公司亦计划于条件具备后开展用于宫颈癌、肝细胞癌、鼻咽癌、头颈部鳞癌、非小细胞肺癌等潜在适应症治疗的相关2期临床试验。
本研究为评估不同剂量HLX43在经一线标准治疗失败或不可耐受毒性的复发/ 转移性食管鳞癌患者中的有效性和安全性的2期临床试验。筛选合格的受试者将接受每3周一次(Q3W)HLX43治疗。本研究主要目的是评估HLX43在复发/ 转移性食管鳞癌中的临床疗效。次要目的是评估安全性和耐受性、药代动力学特征及免疫原性、和潜在预测性生物标志物。
截至本公告日，于全球范围内尚无靶向PD-L1的抗体偶联药物获批上市。
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