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A Phase I Open-label Study for Subjects With Advanced Malignancies

2019-10-28 13:56:53 | BioPortfolio

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.`

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

Conditions

Advanced Solid Malignancies

Intervention

PT01 (Pegtomarginase)

Location

Mayo Clinic
Phoenix
Arizona
United States
85054

Status

Not yet recruiting

Source

Athenex, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-28T13:56:53-0400

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