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评价注射用ATAP-M8在晚期实体瘤患者中单次/多次给药的安全性、耐受性和药代动力学特征Ⅰ期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of single/multiple administration of ATAP-M8 for injection in patients with advanced solid tumors
主要目的:评价注射用ATAP-M8在晚期实体瘤患者中单次/多次给药的安全性和耐受性;
次要目的:评价注射用ATAP-M8在晚期实体瘤患者中单次/多次给药的药代动力学特征和免疫原性特征;评价注射用ATAP-M8治疗晚期实体瘤的初步疗效;探索注射用ATAP-M8治疗晚期实体瘤的Ⅱ期研究推荐剂量(RP2D)。
[Translation] Primary purpose: To evaluate the safety and tolerability of single/multiple administration of ATAP-M8 for injection in patients with advanced solid tumors;
Secondary purpose: To evaluate the pharmacokinetic characteristics and immunogenicity characteristics of single/multiple administration of ATAP-M8 for injection in patients with advanced solid tumors; To evaluate the preliminary efficacy of ATAP-M8 for injection in the treatment of advanced solid tumors; To explore the recommended dose (RP2D) of Phase II study of ATAP-M8 for injection in the treatment of advanced solid tumors.
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