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Enzyme Inhibitor

PT01 (Pegtomarginase) for Solid Tumors (PT01 Trial)

Phase 1
Waitlist Available
Research Sponsored by Athenex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 0 day 1: predose pt01 (hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the pt01 iv infusion. cycle 1 and beyond, prepose and .5 hour post infusion
Awards & highlights

PT01 Trial Summary

This trial is testing a new drug to see if it is safe and works against cancer.

Eligible Conditions
  • Solid Tumors

PT01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 0 day 1: predose pt01 (hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the pt01 iv infusion. cycle 1 and beyond, prepose and .5 hour post infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 0 day 1: predose pt01 (hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the pt01 iv infusion. cycle 1 and beyond, prepose and .5 hour post infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 criteria.
The maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) together with the biologically effective dose (BED) of PT01.
Secondary outcome measures
Area Under Plasma Concentration-Time Curve (AUC)
Duration of arginine reduction <10% of baseline.
Maximum Observed Plasma Concentration (Cmax) of PT01
+8 more

PT01 Trial Design

1Treatment groups
Experimental Treatment
Group I: Pegtomarginase (PT01)Experimental Treatment1 Intervention
To determine the MTD of PT01 based on the toxicity observed during Cycle 1 of the Dose Escalation Phase and to investigate the safety and tolerability of PT01 when administered intravenously(IV) to subjects with advanced malignancies

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor
26 Previous Clinical Trials
1,906 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase I Open-label Study for Subjects With Advanced Malignancies
2021. "A Phase I Open-label Study for Subjects With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04136834.
~15 spots leftby Apr 2025
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