Pegargiminase is in clinical development for numerous oncology indications.
Drug: Pegargiminase (ADI‑PEG 20) + Pemetrexed and Cisplatin
Lead Institute: Barts Cancer Institute
ATOMIC Study (Phase 3)
Phase 2/3 Study in Subjects with MPM to Assess ADI‑PEG 20 with Pemetrexed and Cisplatin (ATOMIC)
This is a randomized, double-blind, pivotal Phase 2/3 study in patients with non-epithelioid (including biphasic and sarcomatoid histologies) malignant pleural mesothelioma (MPM) to assess the effect of Pegargiminase with pemetrexed and cisplatin, the current first-line standard of care chemotherapies for MPM. The study uses an adaptive biomarker-driven design with an interim analysis to be conducted at the end of Phase 2. Patients in the study are required to have tumor samples submitted for biomarker analysis. This study is being conducted at multiple centers globally and is currently recruiting patients.
Soft Tissue Sarcoma
Drug: Pegargiminase (ADI-PEG 20) + Gemcitabine and Docetaxel
Lead Institute: Washington University School of Medicine
Sarcoma Study (Phase 2)
ADI-PEG 20 in Combination with Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma
This is an open-label, Phase 2 study of Pegargiminase in combination with gemcitabine and docetaxel, a standard second line therapy, for patients with soft tissue sarcoma. The investigator has recently demonstrated that by depleting arginine, Pegargiminase induced metabolic changes to sensitize tumor cells to the killing effect of gemcitabine. The study is intended to assess if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by Pegargiminase. The study expects to enroll a total of 90 patients (including 75 with soft tissue sarcoma, 15 with non-soft tissue sarcoma)
Drug: Pegargiminase (ADI‑PEG 20 + Pembrolizumab
Lead Institute: Taiwan National Institute Cancer Research
Pembrolizumab (Phase 1)
Phase 1 Study of ADI‑PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
This is an open-label, Phase 1b study of Pegargiminase in combination with pembrolizumab in patients with advanced solid cancers who have failed prior treatment. In addition to assessing the safety and tolerability of combining Pegargiminase and pembrolizumab, this study also intends to explore the effect of this combination in head and neck tumors. The study is open and currently recruiting patients.