Shenzhen Anshi Biotechnology Co., Ltd.

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.