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Clinical trials
catalyst calendar across sponsors →Studies where PII is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
20 interventional · 1 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular CarcinomaNCT05317819Overall Survival (OS)Randomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: ADI-PEG20 · Other: Placebo | Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma | 300 | Sep 2028 | ≤ 773 d | 2025-12-18 |
| Study of ADI-PEG 20 Versus Placebo in Subjects With NASHNCT05842512Determine Efficacy of ADI-PEG 20 vs Placebo in the treatment of fatty liver as assessed by change in hepatic fat fractionRandomized · Triple-masked · Treatment | Phase 2 | Recruiting | Drug: ADI-PEG20 · Other: Placebo | Nonalcoholic Steatohepatitis (NASH) | 60 | 2027-12-31 | in 499 d | 2025-09-23 |
| ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma MultiformeNCT04587830Overall survival (OS)Randomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: ADI-PEG 20, Temozolomide, Placebo | Glioblastoma Multiforme (GBM) | 100 | 2027-02-28 | in 193 d | 2025-08-26 |
| Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid LeukemiaNCT05001828Determine the RP2D of ADI-PEG 20 in combination with venetoclax and azacitidine, per the number of subjects with treatment-related adverse events by current CTCAENon-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: ADI-PEG 20 | Acute Myeloid Leukemia, Adult | 38 | May 2026 | — | 2026-01-21 |
| Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)NCT05712694Primary End Point of PFSRandomized · Triple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Lack of Efficacy, no safety concern. | Drug: ADI PEG20 · Other: Placebo | Soft Tissue Sarcoma | 218 | 2026-05-25actual | — | 2026-06-25 |
| Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and CisplatinNCT02709512results2023-10-04Response RateRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: ADI-PEG 20 plus Pem Platinum · Other: Placebo plus Pem Platinum | Mesothelioma | 249 | 2022-08-15actual | — | 2023-10-04 |
| Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular CarcinomaNCT02102022Objective response rate (ORR)Open-label · Treatment | Phase 1/2 | Terminated | Drug: ADI-PEG 20 plus modified FOLFOX6 | Advanced Gastrointestinal (GI) Malignancies, Hepatocellular Carcinoma, Gastric Cancer, Colorectal Cancer | 140 | Feb 2020actual | — | 2022-04-25 |
| Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AMLNCT02875093Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study Termination | Drug: ADI-PEG 20, Cytarabine | Acute Myeloid Leukemia | 23 | 2019-07-10actual | — | 2020-03-05 |
| Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid CancersNCT03254732Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with Pembrolizumab in Advanced Solid CancersOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Changing Corporate Priorities | Drug: ADI PEG20, Pembrolizumab | Advanced Solid Cancers | 33 | 2019-05-07actual | — | 2022-04-27 |
| Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and CisplatinNCT02029690Define initial estimates of efficacy, measured by RECIST 1.1 criteria for non-squamous NSCLC, advanced peritoneal mesothelioma, metastatic uveal melanoma, HCC, glioma and sarcomatoid cancers for ADI-PEG 20 in combination with pemetrexed and cisplatin.Open-label · Treatment | Phase 1 | Terminated | Drug: ADI-PEG 20 | Pleural Mesothelioma Malignant Advanced, Peritoneal Mesothelioma Malignant Advanced, Non-squamous Non-small Cell Lung Carcinoma, Uveal Melanoma, Hepatocellular Carcinoma, Glioma, Sarcomatoid Carcinoma | 85 | 2018-08-15actual | — | 2020-09-25 |
| Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic CancerNCT02101580Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with nab-Paclitaxel and Gemcitabine in Advanced Pancreatic CancerOpen-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | Advanced Pancreatic Cancer | 21 | 2017-05-05actual | — | 2020-10-01 |
| PH 2 ADI-PEG 20 Acute Myeloid LeukemiaNCT01910012Response RateOpen-label · Treatment | Phase 2 | Completed | Drug: ADI-PEG 20 | Acute Myeloid Leukemia | 43 | 2016-09-12actual | — | 2020-10-01 |
| PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic TherapyNCT01910025Response RateOpen-label · Treatment | Phase 2 | Completed | Drug: ADI-PEG 20 | Non-Hodgkin's Lymphoma | 18 | 2016-08-31actual | — | 2018-09-18 |
| Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular CarcinomaNCT02006030Determine time to tumor progression (TTP)Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: ADI-PEG 20, Transarterial chemoembolization | Unresectable Hepatocellular Carcinoma | 30 | 2016-07-31actual | — | 2018-09-04 |
| Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast CancerNCT01948843Number of Participants with Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | HER2 Negative Metastatic Breast Cancer | 15 | Apr 2016actual | — | 2016-04-14 |
| Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung CancerNCT01497925Number of Participants with Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | Solid Tumors, Prostate Cancer | 43 | 2016-03-23actual | — | 2018-09-13 |
| Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic MelanomaNCT01665183Number of participants with adverse events.Open-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors | 8 | Feb 2016actual | — | 2016-02-25 |
| Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver CancerNCT02101593Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with sorafenib in advanced HCCOpen-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | Hepatocellular Carcinoma | 8 | Feb 2016actual | — | 2016-03-04 |
| Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic TherapyNCT01287585Overall survivalRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol), Placebo · Other: Best Supportive Care | Hepatocellular Carcinoma | 636 | Jul 2015actual | — | 2019-09-06 |
| Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) DeficientNCT01528384Change in laboratory values.Open-label · Treatment | Phase 1 | Completed | Drug: ADI-PEG 20 | Argininosuccinate Synthetase Deficient | 8 | Mar 2014actual | — | 2014-04-09 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19