17 completed, 8 terminated, 4 recruiting, 4 withdrawn. 21 Phase 2, 20 Phase 1, 5 Phase 3.
Follow ADI PEG20: new trials by email Literature Review of ADI PEG20 trials Research Report on ADI PEG20
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG) ADI-PEG 20 (Arginine deiminase pegylated), Temozolomide (TMZ), Standard of Care Radiation Therapy (RT) - Glioblastoma, High-Grade Glioma (WHO III-IV) | Phase 1 / Phase 2 | Not yet recruiting | Sabine Mueller, MD, PhD | 97 | 2027-06-01 | 2026-11-09 |
| ADI-PEG20, Obesity and Prediabetes ADI-PEG20, Placebo - Obesity, PreDiabetes | Phase 2 | Withdrawn | Washington University School of Medicine | 2024-04-01 | 2024-11-07 | |
| Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma ADI PEG20, Ifosfamide, Radiotherapy - Soft Tissue Sarcoma, Sts | Phase 1 | Terminated | Washington University School of Medicine | 6 | 2024-03-14 | 2026-09-03 |
| Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) ADI-PEG 20, Cabazitaxel, Carboplatin - Prostate Cancer | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 30 | 2024-02-29 | 2026-09-18 |
| Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma ADI-PEG20 - Hepatocellular Carcinoma | Phase 2 | Unknown | Chang Gung Memorial Hospital | 120 | 2023-12-01 | 2023-09-13 |
| Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC) ADI PEG20, Placebo - Soft Tissue Sarcoma | Phase 3 | Terminated | Polaris Group | 218 | 2023-11-29 | 2026-06-25 |
| Study of ADI-PEG 20 Versus Placebo in Subjects With NASH ADI-PEG20, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Recruiting | Polaris Group | 60 | 2023-09-13 | 2025-09-23 |
| A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma Atezolizumab, Bevacizumab, ADI-PEG 20 - Metastatic Hepatocellular Carcinoma | Phase 1 / Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2023-08-08 | 2024-08-26 | |
| ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers ADI-PEG 20, Gemcitabine, Docetaxel - Non Small Cell Lung Cancer, Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | Washington University School of Medicine | 31 | 2023-04-05 | 2026-07-27 |
| Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer Nivolumab, Pegargiminase, Resection - Resectable Hepatocellular Carcinoma | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2022-04-13 | 2023-02-16 | |
| Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia ADI-PEG 20 - Acute Myeloid Leukemia, Adult | Phase 1 | Active not recruiting | Polaris Group | 38 | 2022-04-05 | 2026-10-15 |
| Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma ADI-PEG20, Placebo - Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma | Phase 3 | Recruiting | Polaris Group | 300 | 2022-03-14 | 2025-12-18 |
| ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme ADI-PEG 20, Temozolomide, Placebo - Glioblastoma Multiforme (GBM) | Phase 2 | Active not recruiting | Polaris Group | 100 | 2020-09-14 | 2025-08-26 |
| A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma Temozolomide, Lomustine, Regorafenib - Glioblastoma | Phase 2 / Phase 3 | Recruiting | Global Coalition for Adaptive Research | 2250 | 2019-07-30 | 2026-11-02 |
| Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma ADI PEG20, Nivolumab, Ipilimumab - Uveal Melanoma | Phase 1 | Completed | Memorial Sloan Kettering Cancer Center | 9 | 2019-04-16 | 2025-05-15 |
| Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin Atezolizumab, Pemetrexed, Carboplatin - Carcinoma, Non-Small-Cell Lung | Phase 1 | Withdrawn | Queen Mary University of London | 2018-06-01 | 2020-02-25 | |
| ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer pegylated arginine deiminase, Gemcitabine, Docetaxel - Soft Tissue Sarcoma | Phase 2 | Completed | Washington University School of Medicine | 98 | 2018-05-09 | 2025-12-11 |
| Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum - Mesothelioma | Phase 2 / Phase 3 | Completed | Polaris Group | 249 | 2017-08-01 | 2023-10-04 |
| Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers ADI PEG20, Pembrolizumab - Advanced Solid Cancers | Phase 1 | Terminated | Polaris Group | 33 | 2017-07-14 | 2022-04-27 |
| Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML ADI-PEG 20, Cytarabine - Acute Myeloid Leukemia | Phase 1 | Terminated | Polaris Group | 23 | 2017-01-20 | 2020-03-05 |
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Carcinoma, Hepatocellular (8) · Melanoma (4) · Glioblastoma (3) · Leukemia, Myeloid, Acute (3) · Sarcoma (3) · Uveal Melanoma (3) · Carcinoma, Non-Small-Cell Lung (2) · Glioma (2) · Mesothelioma, Malignant (2) · Neoplasms (2) · Prostatic Neoplasms (2) · Small Cell Lung Carcinoma (2) · Carcinoma (1) · Colorectal Neoplasms (1) · Ichthyosis, X-Linked (1)
Polaris Group (20) · Washington University School of Medicine (4) · M.D. Anderson Cancer Center (3) · FDA Office of Orphan Products Development (2) · Ludwig Institute for Cancer Research (2) · Barts & The London NHS Trust (1) · Chang Gung Memorial Hospital (1) · Global Coalition for Adaptive Research (1) · Memorial Sloan Kettering Cancer Center (1) · Queen Mary University of London (1) · Sabine Mueller, MD, PhD (1) · University of Miami (1)
United States (28) · Taiwan (15) · United Kingdom (6) · Italy (3) · South Korea (3) · Australia (2) · Canada (2) · China (2) · Germany (2) · Belgium (1) · France (1) · Switzerland (1) · Vietnam (1)
John S Bomalaski (3) · John S Bomalaski, MD (2) · Mia Weiss, M.D. (2) · Peter Szlosarek (2) · Siqing Fu, MD (2) · Alexander Shoushtari, MD (1) · Ana Aparicio, MD (1) · Anna Pavlick, DO (1) · Christine Auberle, M.D. (1) · Cynthia Herzog, MD (1) · Gary Schwartz, MD (1) · Ghassan Abou-Alfa, MD (1) · James Harding, MD (1) · Jedd Wolchok, MD, PhD (1) · John S Bomalaski, M.D. (1)
PMID 22472884, PMID 22864522, PMID 27584578, PMID 28900115, PMID 30796035, PMID 33358660, PMID 33787078, PMID 34382365, PMID 34589965, PMID 35466524, PMID 38358753, PMID 38773224, PMID 41980234
R01CA227115 (1)