[Translation] An open, first-in-human, dose-escalation and expanded Phase I clinical study of the safety, tolerability and pharmacokinetic characteristics of JS201 in patients with advanced malignancies
主要目的: 评价JS201在晚期恶性肿瘤患者中的安全性和耐受性,评价JS201的最大耐受剂量(MTD,如果可能)和剂量限制性毒性(DLT);确定Ⅱ期临床研究推荐剂量(RP2D);
次要目的:评价JS201在晚期恶性肿瘤患者体内的免疫原性;评价JS201在晚期恶性肿瘤患者体内的药代动力学(PK)特征;评价JS201在晚期恶性肿瘤患者体内的药效动力学(PD)特征;初步评估JS201治疗晚期恶性肿瘤的有效性;
[Translation] Primary objectives: To evaluate the safety and tolerability of JS201 in patients with advanced malignant tumors, to evaluate the maximum tolerated dose (MTD, if possible) and dose-limiting toxicity (DLT) of JS201; to determine the recommended dose (RP2D) for Phase II clinical studies;
Secondary objectives: To evaluate the immunogenicity of JS201 in patients with advanced malignant tumors; to evaluate the pharmacokinetic (PK) characteristics of JS201 in patients with advanced malignant tumors; to evaluate the pharmacodynamic (PD) characteristics of JS201 in patients with advanced malignant tumors; to preliminarily evaluate the effectiveness of JS201 in the treatment of advanced malignant tumors;