[Translation] A phase I clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of AST2169 liposome injection in patients with advanced solid tumors with KRAS G12D mutation
主要目的:评价AST2169在晚期实体瘤受试者中的安全性和耐受性;确定AST2169的剂量限制性毒性(DLT)、最大耐受剂量和(或)II期推荐剂量(RP2D)。
次要目的:评价AST2169在晚期实体瘤受试者中的药代动力学(PK)特征;初步评价AST2169在晚期实体瘤受试者中的有效性;
探索性目的:评价生物标志物与疗效的相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of AST2169 in subjects with advanced solid tumors; to determine the dose-limiting toxicity (DLT), maximum tolerated dose and/or Phase II recommended dose (RP2D) of AST2169.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of AST2169 in subjects with advanced solid tumors; to preliminarily evaluate the efficacy of AST2169 in subjects with advanced solid tumors;
Exploratory objective: To evaluate the correlation between biomarkers and efficacy.