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Amino Acids

BCT-100

Arginine

PEG-BCT-100 at 0.5 mg/kg administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT- 100 will be administered at 0.5 mg/kg on days 22 (week 4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at 0.5 mg/kg. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at 0.5 mg/kg until disease progression at the discretion of the investigator.

PEG-BCT-100 at 1.0 mg/kg administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT- 100 will be administered at 1.0 mg/kg on days 22 (week4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at 1.0 mg/kg. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at 1.0 mg/kg until disease progression at the discretion of the investigator.

PEG-BCT-100 at 1.7 mg/kg administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT- 100 will be administered at 1.7 mg/kg on days 22 (week 4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at 1.7 mg/kg. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at 1.7 mg/kg until disease progression at the discretion of the investigator.

PEG-BCT-100 at 1.7 mg/kg administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT- 100 will be administered at 2.7 mg/kg on days 22 (week 4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at 2.7 mg/kg. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at 2.7 mg/kg until disease progression at the discretion of the investigator.

PEG-BCT-100 at 1.7 mg/kg administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT- 100 will be administered at 4.0 mg/kg on days 22 (week 4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at 4.0 mg/kg. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at 4.0 mg/kg until disease progression at the discretion of the investigator.

PEG-BCT-100 at a dose to be determined administered as a single dose on day 1 (week 1); if not DLTs are observed, PEG-BCT-100 will be administered at at a dose to be determined on days 22 (week 4) and 29 (week 5). Patients responding to treatment or with stable disease may receive 8 additional weekly administrations of PEG-BCT-100 at at a dose to be determined. Beyond week 13, patients responding to treatment or with stable disease may continue to receive weekly PEG-BCT-100 at at a dose to be determined until disease progression at the discretion of the investigator.

PEG-BCT-100

Alberto Bessudo, MD

Steven O'Day, MD

The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as an infusion to treat patients who bear advanced solid tumors that are dependent on arginine (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have progressed after receiving approved or established therapies. This is a Phase 1 study; PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.

This is a phase 1, multiple sites, open label and non-randomized study to evaluate the safety of PEG-BCT-100. Patient enrollment and sample size will follow a classical 3 + 3 dose-escalation design. The study will enroll a maximum of 36 patients. Cohorts of 3 patients will receive an initial single dose of PEG-BCT-100 beginning at 0.5 mg/kg. Single dose safety parameters including hematology and chemistry laboratory profiles will be monitored for 3 weeks. Patients not demonstrating a dose-limiting toxicity (DLT) following the single dose may then receive two additional doses of PEG-BCT-100 at the same dose level on Day 22 and Day 29. After these 2 additional doses, patients will undergo a full tumor and safety assessment after Day 29. Patients whose cancer is stable or responding may then receive weekly doses of PEG-BCT- 100 until disease progression. Dose escalations are planned for the next cohorts of 3 patients, which will be enrolled after Day 22 of the previous cohort, assuming that no single dose DLTs were reported. Each cohort of 3 patients may begin weekly administration if there is no DLTs by Day 22, and if the previous and lower dose cohort has successfully passed Week 4 of the study (doses on Days 1, and 22 + one week).

As of the beginning of 2018, an additional 22 patients will include only malignant melanoma patients. All newly enrolled patients will be enrolled at the dose level of Cohort Four (2.7 mg/kg) of PEG-BCT-100.

Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors

Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors: Dose Escalation, Safety and PK/PD

The optimal biological dose (OBD) of PEG-BCT-100 will be calculated based on the pharmacodynamics (PD) endpoint of plasma arginine depletion relative to plasma pharmacokinetics (PK) of PEG-BCT-100

Evaluate objective tumor responses by RECIST (Response Evaluation Criteria In Solid Tumors)

Determine the dose-related peak to trough concentrations of plasma PEG-BCT-100 over time

To determine the magnitude of plasma arginine depletion (AD) relative to the dose of PEG-BCT-100

the time and duration of effective AD assessed by plasma arginine \<8 µM relative to the plasma peak and time to clearance over the range of PEG-BCT-100 doses

the temporal and quantitative relationships of depleted plasma arginine to dose and plasma concentrations of PEG-BCT-100

the temporal and quantitative relationships of depleted plasma arginine to dose and plasma concentrations of PEG-BCT-100; and, The relationship of PEG-BCT-100 dose and its resultant effective AD to changes in AFP/PSA and/or tumor symptoms and measurements.

Oncotherapeutics

Bio-Cancer Treatment International Limited

Rare Diseases

Childhood Acute Lymphoblastic Leukemia

PEG- BCT-100 in patients with Leukaemia Starting dose 1600U/Kg IV infusion weekly

PEG- BCT-100 in patients with Neuroblastoma Starting dose 1600U/Kg IV infusion weekly

PEG- BCT-100 in patients with Sarcomas Starting dose 1600U/Kg IV infusion weekly

PEG- BCT-100 in patients with High Grade Gliomas Starting dose 1600U/Kg IV infusion weekly

PEG- BCT-100

Francis J Mussai, DPhil

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.

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

A Phase I/II Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) in Relapsed/Refractory Cancers of Children and Young Adults

Safety profile as measured by the occurrence/non-occurrence of DLT within 28 days of treatment with BCT-100.

o Optimal dose as measured by the complete depletion of arginine. This is defined as AAD \<8μM arginine in the blood after 3 doses of BCT-100.

Disease response (Complete Response (CR) or Partial Response (PR)) after 8 weeks of treatment with BCT-100

Incidence and severity of Adverse Events (AEs) defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4

Disease response ( CR / PR) according to Cheson criteria

Disease response ( CR / PR) according to RECIST criteria

Disease response ( CR / PR) according to RANO criteria

Disease response ( CR / PR) according to INCR criteria

BCT-100 concentration in cerebrospinal fluid

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors	NCT02285101	Melanoma Prostate Adenoc...	PEG-BCT-100	18 Years -	Bio-Cancer Treatment International Limited
A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)	NCT03455140	Cancer Pediatric Solid... Pediatric AML Pediatric ALL	PEG- BCT-100	1 Year - 25 Years	University of Birmingham
Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors	NCT02285101	Melanoma Prostate Adenoc...	PEG-BCT-100	18 Years -	Bio-Cancer Treatment International Limited
Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors	NCT02285101	Melanoma Prostate Adenoc...	PEG-BCT-100	18 Years -	Bio-Cancer Treatment International Limited
A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)	NCT03455140	Cancer Pediatric Solid... Pediatric AML Pediatric ALL	PEG- BCT-100	1 Year - 25 Years	University of Birmingham

Spots Global Cancer Trial Database for arginase

Every month we try and update this database with for arginase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for arginase

Every month we try and update this database with for arginase cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for arginase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.