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评价双特异性抗体MR001在晚期实体瘤患者中的安全性、耐受性的临床研究
[Translation] Clinical study to evaluate the safety and tolerability of bispecific antibody MR001 in patients with advanced solid tumors
主要目的:评估双特异性抗体MR001在晚期实体瘤患者中的安全性和耐受性;确定双特异性抗体MR001的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。次要目的:评估双特异性抗体MR001在晚期实体瘤患者者中的药代动力学特征,获取初步药代动力学参数;评估双特异性抗体MR001在晚期实体瘤患者中的初步疗效,为后续临床试验推荐剂量提供依据;评价双特异性抗体MR001在晚期实体瘤患者中的免疫原性。探索性目的:探索双特异性抗体MR001在晚期实体瘤患者中的药效学指标的特征。
[Translation] Main purpose: To evaluate the safety and tolerability of bispecific antibody MR001 in patients with advanced solid tumors; to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of bispecific antibody MR001. Secondary purpose: To evaluate the pharmacokinetic characteristics of bispecific antibody MR001 in patients with advanced solid tumors and obtain preliminary pharmacokinetic parameters; to evaluate the preliminary efficacy of bispecific antibody MR001 in patients with advanced solid tumors to provide guidance for subsequent Clinical trials provide the basis for recommended doses; evaluate the immunogenicity of bispecific antibody MR001 in patients with advanced solid tumors. Exploratory purpose: To explore the characteristics of pharmacodynamic indicators of bispecific antibody MR001 in patients with advanced solid tumors.
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