NCT04136834

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

A Phase I Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity o f Ascending Doses of PT0I (Pegtomarginase) in Subjects With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Athenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.'

Detailed 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.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	PT01 (Pegtomarginase)	PT01 (Pegtomarginase) breaks down arginine in the blood stream, reducing the supply of arginine and stopping the cancer cells from growing. Normal cells can continue to make their own arginine inside the cell, so PT01 targets the rapidly growing cancer cells.

Timeline

• Start date: 2021-04-21
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-10-23
• Last updated: 2021-08-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study