[Translation] An open-label, multiple-dose, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of IUAb190708 injection in subjects with advanced or recurrent solid tumors
主要目的:1.评估 IUAb190708 注射液在晚期或复发实体瘤受试者上多次给药后的安全性和耐受性;2.确定 IUAb190708 注射液最大耐受剂量(MTD)、剂量限制性毒性(DLT),以及II 期临床推荐剂量(RP2D)。
次要目的:1.评估 IUAb190708 注射液多次给药的药代动力学(PK)特征;2. 评估 IUAb190708 注射液免疫原性;3.评估 IUAb190708 注射液的初步抗肿瘤活性。
[Translation] Primary objectives: 1. To evaluate the safety and tolerability of IUAb190708 injection after multiple administration in subjects with advanced or recurrent solid tumors; 2. To determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dose (RP2D) for Phase II clinical trials of IUAb190708 injection.
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of IUAb190708 injection after multiple administrations; 2. To evaluate the immunogenicity of IUAb190708 injection; 3. To evaluate the preliminary anti-tumor activity of IUAb190708 injection.