Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
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.