Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

PHASE1UnknownINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 9, 2023

Primary Completion Date

April 15, 2024

Study Completion Date

December 31, 2024

Conditions
Advanced Solid Tumor
Interventions
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."

Trial Locations (1)

90007

RECRUITING

University of Southern California, Los Angeles

Sponsors
All Listed Sponsors
lead

Biostar Pharma, Inc.

INDUSTRY

NCT05681000 - Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter