Shanghai Aoqi Medical Technology Co Ltd

The main purpose of the dose exploration phase is to evaluate the safety and tolerability of multiple oral administration of Enosate tablets in patients with advanced (terminal) pancreatic cancer, determine the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) for Phase II clinical trials, and provide a basis for the dosing regimen and dose of subsequent clinical trials. The main purpose of the study extension phase is to evaluate the preliminary efficacy of Enosate tablets in patients with advanced (terminal) pancreatic cancer through objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).

Primary objective: To investigate the effect of food on the pharmacokinetics of a single dose of the investigational drug in healthy subjects. Secondary objective: To evaluate the safety and tolerability of a single oral dose of the investigational drug in healthy subjects; To evaluate the plasma pharmacokinetic characteristics of the investigational drug metabolites under different dietary conditions in healthy subjects. Exploratory objective: To evaluate the excretion of the investigational drug and its metabolites in urine and feces in healthy subjects.

Main objectives: (1) To explore the safety and maximum tolerated dose (MTD) of oral investigational drugs in patients with advanced malignant tumors, and to determine the recommended dosing regimen for Phase II clinical trials; (2) To study the pharmacokinetic characteristics of single and multiple doses of oral investigational drugs in patients with advanced malignant tumors; Secondary objectives: To preliminarily evaluate the anti-tumor efficacy of investigational drugs through indicators such as objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).