At least 4 dose cohorts are planned, and 16-28 cases are expected.~Cohort 1 and 2: 2 cases are planned for each.~Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design.
The purpose of this trial is to evaluate the safety and tolerability of Utidelone Capsule in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of Utidelone Capsule in patients with advanced solid tumors, preliminarily assess the anti-tumor activity of Utidelone Capsule in patients with advanced solid tumors via objective radiologic tumor response using RECIST 1.1, and to recommend the dose and dosage regimen for subsequent clinical trials.