NCT05681000

Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Biostar Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

At least 4 dose cohorts are planned, and 16-28 cases are expected. 1. Cohort 1 and 2: 2 cases are planned for each. 2. Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Utidelone Capsule	At least 4 dose cohorts are planned, and 16-28 cases are expected. 1. Cohort 1 and 2: 2 cases are planned for each. In cohort 1, the subjects will receive Utidelone Capsule at a dose of 25 mg/m2/d for 5 days, in a 21-day cycle. In cohort 2, the subjects will receive Utidelone Capsule at a dose of 50 mg/m2/d for 5 days, in a 21-day cycle. 2. Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design. The subjects in these cohorts will receive Utidelone Capsule at 75 mg/m2/d for 5 days, 100 mg/m2/d for 5 days, 100 mg/m2/d for 7 days, and 120 mg/m2/d for 7 days in a 21-day cycle respectively.

Timeline

• Start date: 2023-06-09
• Primary completion: 2024-04-15
• Completion: 2024-12-31
• First posted: 2023-01-11
• Last updated: 2023-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study