NCT04136834 (PT01) is a Phase 1 clinical trial of PT01 (Pegtomarginase) in Advanced Solid Malignancies, sponsored by Athenex, Inc..

Who is sponsoring NCT04136834?

NCT04136834 is sponsored by Athenex, Inc..

What drugs are being tested in NCT04136834?

Interventions in NCT04136834: PT01 (Pegtomarginase).

What condition does NCT04136834 study?

NCT04136834 studies Advanced Solid Malignancies.

Is NCT04136834 still recruiting?

NCT04136834 is currently status unknown. Last updated 17 August 2021.

Last reviewed 2021-08-17 · How we verify

NCT04136834: PT01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 17 August 2021

What this trial tests

Phase 1 trial testing PT01 (Pegtomarginase) in Advanced Solid Malignancies in 62 participants. Status unknown.

Timeline

21 April 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Athenex, Inc.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	21 April 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	3 locations across United States

Drugs / interventions tested

PT01 (Pegtomarginase) — full drug profile →

Conditions studied

Advanced Solid Malignancies — all drugs for Advanced Solid Malignancies →

Sponsor

Athenex, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.'

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Amino acid metabolism in health and disease.
Ling ZN, Jiang YF, Ru JN, Lu JH, et al · · 2023 · cited 291× · PMID 37699892 · DOI 10.1038/s41392-023-01569-3
Human arginase I: a potential broad-spectrum anti-cancer agent.
Anakha J, Prasad YR, Sharma N, Pande AH. · · 2023 · cited 5× · PMID 37152001 · DOI 10.1007/s13205-023-03590-3

Verify or expand the search:

Other recruiting trials for Advanced Solid Malignancies

Currently open trials in the same condition.

NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
NCT06927297 — Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors · Phase 1 · recruiting
NCT06760481 — Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIG · Phase 1 · active not recruiting
NCT06899061 — Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saru · Phase 1 · active not recruiting
NCT05417594 — Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignanc · Phase 1, PHASE2 · recruiting

Other Athenex, Inc. trials

Trials by the same sponsor.

NCT03892018 — The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol · Phase 1 · terminated
NCT04993040 — A PK Study of Oraxol in Breast Cancer Patients · Phase 1 · completed
NCT03544567 — A Study of Oraxol in Subjects With Cutaneous Angiosarcoma · Phase 2 · completed
NCT03588039 — Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors · Phase 1 · terminated
NCT03575780 — Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subje · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04136834 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Athenex, Inc.
Last refreshed: 17 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04136834.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing