Part 1 is a dose-escalation trial, and it's an open design; Part 2 is a pharmacokinetic comparison and food effect study, and it's an open, controlled study.
This study has two parts. Part 1 is a dose-escalation trial and Part 2 is a pharmacokinetic comparison and food effect study. The primary objectives are to evaluate the safety and tolerability of Utidelone Capsules in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT). The secondary objectives are: 1. to evaluate the absolute bioavailability of Utidelone capsules relative to Utidelone injection; 2. to evaluate the pharmacokinetic profile of Utidelone capsules in patients with advanced solid tumors; 3. to preliminarily evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors; and 4. to recommend doses and dosing regimens for subsequent clinical trials.