[Translation] An open-label, multicenter, first-in-human phase I study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SIM0532 in adult subjects with advanced solid tumors.
主要目的:第1部分(剂量递增):评价SIM0532的安全性和耐受性,并确定最大耐受剂量(MTD);第2部分(剂量扩展):确定SIM0532的推荐剂量(RD)并初步评价SIM0532的抗肿瘤活性
次要目的:进一步描述SIM0532的安全性和耐受性特征;描述SIM0532的药代动力学(PK)特性;进一步评价SIM0532的抗肿瘤活性
[Translation] Primary Objectives: Part 1 (Dose Elevation): To evaluate the safety and tolerability of SIM0532 and determine the maximum tolerated dose (MTD); Part 2 (Dose Extension): To determine the recommended dose (RD) of SIM0532 and preliminarily evaluate its antitumor activity. Secondary Objectives: To further describe the safety and tolerability characteristics of SIM0532; to describe the pharmacokinetic (PK) properties of SIM0532; to further evaluate the antitumor activity of SIM0532.