君实生物(688180.SH)：NCT04601285研究已完成首例患者给药
格隆汇11月25日丨君实生物(688180.SH)公布，近日，公司产品注射用重组人源化抗Trop2单抗-Tub196偶联剂(项目代号：JS108)的I期临床研究(NCT04601285研究)已完成首例患者给药。
JS108为注射用重组人源化抗Trop2单抗-Tub196偶联剂。Trop2是重要的肿瘤发展因子，其高表达于多种肿瘤，如乳腺癌、胃癌、非小细胞肺癌、小细胞肺癌、结肠癌、胰腺癌等，可促进肿瘤细胞增殖、侵袭、转移扩散等过程，其高表达与肿瘤患者生存期缩短及不良预后密切相关，因此以Trop2为靶点的抗肿瘤药物研究具有重要意义。2020年7月，JS108临床试验申请获得国家药品监督管理局批准。
近年来，分子靶向药物联合化疗药物治疗恶性肿瘤已经成为多种肿瘤的成熟治疗方案，并且取得了很好的疗效，但是比单用化疗药物治疗恶性肿瘤增加了副作用和风险。抗体偶联药物(Antibody Drug Conjugates，ADCs)是单克隆抗体与抗肿瘤毒性小分子的偶联产物，通过化学键将细胞毒药物与单克隆抗体偶联组成ADCs，并利用抗体可特异性识别肿瘤细胞的特性，可“精确”地把毒性小分子运送到肿瘤细胞。因此，在提高肿瘤部位药物浓度的同时降低了正常组织、器官的药物浓度，达到了高效低毒的抗肿瘤效果。
NCT04601285研究是一项旨在评估JS108用于治疗晚期实体瘤受试者的安全性、耐受性、PK特征及有效性的开放、首次人体的I期临床研究。该研究的主要研究终点为最大耐受剂量(MTD)、剂量限制性毒性(DLT)事件、不良事件(AE)发生率及严重程度、异常实验室指标。次要研究终点为PK特征、免疫原性、有效性、Trop2蛋白表达水平。研究分为3个阶段：剂量递增阶段、剂量拓展阶段和临床拓展阶段，三个阶段分别计划入组约16-36例、12-27例和60-90例晚期实体瘤受试者。
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