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Clinical Trial Summary

This is a first-in-human (FIH) Phase 1 dose escalation study to evaluate the safety, tolerability, PK, PD, and preliminary activity of PT01 administered IV in subjects with advanced malignancies.'


Clinical Trial Description

The study consists of a Dose Escalation Phase and a Dose Expansion Phase, both of which include a 28-day Screening Period, Baseline, a Treatment Period (comprised of 28-day cycles with weekly dosing on Days 1, 8, 15, and 22), and a Follow-up Period. Unique to the Dose Escalation Phase is the inclusion of Cycle 0 during which a single dose of PT01 will be administered before Cycle 1 for detailed exploration of the PK/PD relationship. All PT01 IV doses will be administered at the clinical site. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04136834
Study type Interventional
Source Athenex, Inc.
Contact Donna Madore
Phone 5088264444
Email ext-dmadore@athenex.com
Status Recruiting
Phase Phase 1
Start date April 21, 2021
Completion date December 1, 2022

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