采用ReT01 ACT注射液治疗晚期实体瘤的单臂、开放Ⅰ期临床试验
[Translation] A single-arm, open-label Phase I clinical trial using ReT01 ACT injection in the treatment of advanced solid tumors
主要目的:评价在晚期实体瘤受试者中输注ReT01 ACT注射液的耐受性和安全性,并确定最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
次要目的:1、评价在晚期实体瘤受试者中输注ReT01 ACT注射液的药代动力学(PK)和药效学(PD)特征。2、初步评价在晚期实体瘤受试者中输注ReT01 ACT注射液的临床有效性。
[Translation] Primary objective: To evaluate the tolerability and safety of ReT01 ACT injection infusion in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D).
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of ReT01 ACT injection infusion in subjects with advanced solid tumors. 2. To preliminarily evaluate the clinical effectiveness of ReT01 ACT injection infusion in subjects with advanced solid tumors.
100 Clinical Results associated with Beijing Anweisen Biomedicine Co., Ltd.
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