[Translation] An open-label, multicenter, Phase I/II dose-escalation, optimization and expansion clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of MRG006A in patients with advanced solid tumors
主要目的:评价MRG006A治疗晚期实体瘤患者的安全性和耐受性;确定MRG006A的最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
次要目的:描述MRG006A的药代动力学及免疫原性特征;研究者评估的客观缓解率(ORR)、疾病控制率(DCR)、缓解持续时间(DoR)和无进展生存期(PFS);评估MRG006A对晚期实体瘤患者QT间期延长的影响。
[Translation] Primary objectives: To evaluate the safety and tolerability of MRG006A in the treatment of patients with advanced solid tumors; to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of MRG006A.
Secondary objectives: To describe the pharmacokinetic and immunogenic characteristics of MRG006A; investigator-assessed objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS); to evaluate the effect of MRG006A on QT interval prolongation in patients with advanced solid tumors.