AST-001(Astrogen)

Primary objectives: - To evaluate the safety and tolerability of AST-001 intravenous infusion in subjects with solid tumors - To evaluate the pharmacokinetic characteristics of AST-001 and its main metabolite AST 2660 in subjects with solid tumors - To determine the maximum tolerated dose (MTD) of AST-001 monotherapy in subjects with solid tumors and determine the recommended dose (RP2D) for Phase II clinical trials Secondary objectives: - To preliminarily evaluate the efficacy of AST-001 monotherapy in the treatment of malignant tumors based on the objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS) of the subjects - To explore the relationship between AKR1C3 expression determined by immunohistochemistry (IHC) in tumor tissues and efficacy - To evaluate the metabolite spectrum of AST-001 in humans Exploratory objectives: - To explore the mutation status of genes related to DNA damage repair