28
Participants
Start Date
June 9, 2023
Primary Completion Date
April 15, 2024
Study Completion Date
December 31, 2024
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."
RECRUITING
University of Southern California, Los Angeles
Lead Sponsor
Biostar Pharma, Inc.
INDUSTRY