[Translation] A Phase I study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ANS03 monotherapy in subjects with locally advanced or metastatic solid tumors harboring ROS1 or NTRK aberrations
第1部分(剂量递增)
主要目的:评价ANS03在携带ROS1或NTRK异常的局部晚期或转移性实体瘤受试者中的耐受性和安全性;确定最大耐受剂量(MTD)和/或推荐剂量。
次要目的:评估ANS03的药代动力学(PK)特征;评价ANS03在携带ROS1或NTRK异常的局部晚期或转移性实体瘤受试者中的临床疗效。
探索性目的:评价ANS03可能的耐药机制;探索不同形式的ROS1/NTRK异常与疗效变量之间的关系。
第2部分(剂量扩展):
主要目的:评价ANS03在携带ROS1或NTRK异常的局部晚期或转移性实体瘤受试者中的抗肿瘤活性。
次要目的:评价ANS03在携带ROS1或NTRK异常的局部晚期或转移性实体瘤受试者中的临床疗效;评价ANS03的总体耐受性和安全性;确定RP2D;评估ANS03的药代动力学(PK)特征。
探索性目的:评价ANS03可能的耐药机制;探索不同形式的ROS1/NTRK异常与疗效变量之间的关系。
[Translation] Part 1 (Dose Escalation)
Primary Objectives: To evaluate the tolerability and safety of ANS03 in subjects with locally advanced or metastatic solid tumors carrying ROS1 or NTRK abnormalities; to determine the maximum tolerated dose (MTD) and/or recommended dose.
Secondary Objectives: To evaluate the pharmacokinetic (PK) characteristics of ANS03; to evaluate the clinical efficacy of ANS03 in subjects with locally advanced or metastatic solid tumors carrying ROS1 or NTRK abnormalities.
Exploratory Objectives: To evaluate the possible resistance mechanisms of ANS03; to explore the relationship between different forms of ROS1/NTRK abnormalities and efficacy variables.
Part 2 (Dose Expansion):
Primary Objectives: To evaluate the anti-tumor activity of ANS03 in subjects with locally advanced or metastatic solid tumors carrying ROS1 or NTRK abnormalities.
Secondary Objectives: To evaluate the clinical efficacy of ANS03 in subjects with locally advanced or metastatic solid tumors carrying ROS1 or NTRK abnormalities; to evaluate the overall tolerability and safety of ANS03; to determine the RP2D; to evaluate the pharmacokinetic (PK) characteristics of ANS03.
Exploratory objectives: To evaluate the possible resistance mechanism of ANS03; to explore the relationship between different forms of ROS1/NTRK abnormalities and efficacy variables.