NCT03455140: PARC

A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)

Completed Phase 1, PHASE2 Last updated 2 September 2022

What this trial tests

Phase 1, PHASE2 trial testing PEG- BCT-100 in Cancer in 49 participants. Completed in 22 July 2022.

Timeline

28 August 2018

Primary endpoint
22 July 2022

22 July 2022

Quick facts

Lead sponsor	University of Birmingham
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	28 August 2018
Primary completion	22 July 2022
Estimated completion	22 July 2022
Sites	14 locations across United Kingdom, Netherlands, Australia

Drugs / interventions tested

• PEG- BCT-100

Conditions studied

• Cancer — all drugs for Cancer →
• Pediatric Solid Tumor — all drugs for Pediatric Solid Tumor →
• Pediatric AML — all drugs for Pediatric AML →
• Pediatric ALL — all drugs for Pediatric ALL →

Sponsor

University of Birmingham

Who can join

Adults 1 to 25, any sex, with Cancer or Pediatric Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PARC is an international phase I/II trial evaluating the safety and activity of pegylated recombinant human arginase (BCT-100) in children and young people with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).

Currently the outcomes for these patients are poor and the therapeutic options are limited with a significant toxicity burden. Therefore new treatments which work in different ways to standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults and shown to be active with almost no side-effects. This trial will test whether this dose of BCT-100 is also safe and active in children with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken down in the body and look for new biological markers of treatment response. Up to 64 children with relapsed cancers will be recruited over 2 years.

Publications & conference data

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

1. 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
2. Arginine Signaling and Cancer Metabolism.
   Chen CL, Hsu SC, Ann DK, Yen Y, et al · · 2021 · cited 179× · PMID 34298755 · DOI 10.3390/cancers13143541
3. Cancer nanotechnology: current status and perspectives.
   Kemp JA, Kwon YJ. · · 2021 · cited 117× · PMID 34727233 · DOI 10.1186/s40580-021-00282-7
4. Mitochondrial metabolism as a target for acute myeloid leukemia treatment.
   Panina SB, Pei J, Kirienko NV. · · 2021 · cited 68× · PMID 33883040 · DOI 10.1186/s40170-021-00253-w
5. Macrophage-Derived IL1β and TNFα Regulate Arginine Metabolism in Neuroblastoma.
   Fultang L, Gamble LD, Gneo L, Berry AM, et al · · 2019 · cited 62× · PMID 30545920 · DOI 10.1158/0008-5472.can-18-2139
6. Metabolic Reprogramming of Non-Hodgkin's B-Cell Lymphomas and Potential Therapeutic Strategies.
   Ricci JE, Chiche J. · · 2018 · cited 54× · PMID 30564554 · DOI 10.3389/fonc.2018.00556
7. The role of bone marrow microenvironment (BMM) cells in acute myeloid leukemia (AML) progression: immune checkpoints, metabolic checkpoints, and signaling pathways.
   Bakhtiyari M, Liaghat M, Aziziyan F, Shapourian H, et al · · 2023 · cited 51× · PMID 37735675 · DOI 10.1186/s12964-023-01282-2
8. Tumor metabolic regulators: key drivers of metabolic reprogramming and the promising targets in cancer therapy.
   Huang K, Han Y, Chen Y, Shen H, et al · · 2025 · cited 47× · PMID 39789606 · DOI 10.1186/s12943-024-02205-6