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

Phase 1 Completed 23 enrolled Bio-Cancer Treatment International Limited Oncotherapeutics · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2014-11
Primary completion: 2019-02
Completion: 2019-02

Publications

De Santo C, Cheng P, Beggs A, Egan S, Bessudo A, Mussai F. Metabolic therapy with PEG-arginase induces a sustained complete remission in immunotherapy-resistant melanoma. J Hematol Oncol. 2018 May 18;11(1):68. doi: 10.1186/s13045-018-0612-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PEG-BCT-100	Protein / enzyme biologic	0.5 mg/kg	Intravenous
Subject	PEG-BCT-100	Protein / enzyme biologic	1 mg/kg	Intravenous
Subject	PEG-BCT-100	Protein / enzyme biologic	1.7 mg/kg	Intravenous
Subject	PEG-BCT-100	Protein / enzyme biologic	2.7 mg/kg	Intravenous
Subject	PEG-BCT-100	Protein / enzyme biologic	4 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications