Clinical Trials

Pegargiminase is in clinical development for numerous oncology indications.

Phase 2/3

Hepatic Cell Carcinoma

Drug: Pegargiminase (ADI-PEG 20)
Lead Institute: Taiwan Linkou Chang Gung Memorial Hospital

HCC (Phase 2/3)

A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 with Patients with high concentrations of spermidine and hepatocellular carcinoma that cannot be surgically removed. Unresectable Hepatocellular Carcinoma (HCC)

This is a randomized, placebo-controlled, genotype selected trial, with overall survival (OS) as the primary outcome measure. Subjects will be randomized (1:1) to Pegargiminase (ADI-PEG 20) or placebo, and remain on ADI-PEG 20 or placebo treatment until PD per RECIST 1.1 criteria. CT (or MRI scan) will be performed at baseline and every 12 weeks. All subjects will receive best supportive care.

Phase 2/3

Phase 1

Acute Myeloid Leukemia

Drug: Pegargiminase (ADI-PEG 20)+ Venetoclax and Azacitidine
Lead Institute: MD Anderson Cancer Center

AML (Phase 1)

Phase IA/B Combination Study of ADI‑PEG 20, Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia (AML)

This is an open-label, single arm, phase 1 study of Pegargiminase in combination with Venetoclax and Azacitidine, a standard front-line therapy, for patients with AML. In addition to assessing the safety and tolerability of combining Pegargiminase and Venetoclax and Azacitidine, this study also intends to explore the antitumor effect of this combination in AML.

Phase 1
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