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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: ADI-PEG-20 Clear all
Withdrawn Phase 2 Interventional

ADI-PEG20, Obesity and Prediabetes

NCT05829239
View directory record Official record
Conditions
Obesity, PreDiabetes
Interventions
ADI-PEG20, Placebo
Biological · Other
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years to 22 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Nov 6, 2024 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 2 Interventional Results available

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

NCT03449901
View directory record Official record
Conditions
Soft Tissue Sarcoma
Interventions
pegylated arginine deiminase, Gemcitabine, Docetaxel, Tumor biopsy, Research blood draw
Drug · Procedure
Lead sponsor
Washington University School of Medicine
Other
Eligibility
10 Years and older
Enrollment
98 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
4
States / cities
Palo Alto, California • Santa Monica, California • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2025 · Synced Sep 11, 2026, 5:23 PM EDT
Terminated Phase 1 Interventional

Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma

NCT05813327
View directory record Official record
Conditions
Soft Tissue Sarcoma, Sts, Sarcoma,Soft Tissue
Interventions
ADI PEG20, Ifosfamide, Radiotherapy, Mesna
Drug · Radiation
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 2 Interventional

Testing of ADI-PEG in Hepatocellular Carcinoma

NCT00056992
View directory record Official record
Conditions
Carcinoma, Hepatocellular
Interventions
ADI-PEG 20
Drug
Lead sponsor
FDA Office of Orphan Products Development
Federal
Eligibility
Not listed
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2003
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Sep 11, 2026, 5:23 PM EDT
Terminated Phase 3 Interventional

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

NCT05712694
View directory record Official record
Conditions
Soft Tissue Sarcoma
Interventions
ADI PEG20, Placebo
Drug · Other
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years to 99 Years
Enrollment
218 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
25
States / cities
Phoenix, Arizona • Los Angeles, California • Palo Alto, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient

NCT01528384
View directory record Official record
Conditions
Argininosuccinate Synthetase Deficient
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
4 Years to 18 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 8, 2014 · Synced Sep 11, 2026, 5:23 PM EDT
Terminated Phase 1 Interventional

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

NCT02029690
View directory record Official record
Conditions
Pleural Mesothelioma Malignant Advanced, Peritoneal Mesothelioma Malignant Advanced, Non-squamous Non-small Cell Lung Carcinoma, Uveal Melanoma, Hepatocellular Carcinoma, Glioma, Sarcomatoid Carcinoma
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 24, 2020 · Synced Sep 11, 2026, 5:23 PM EDT
Recruiting Phase 2Phase 3 Interventional

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

NCT03970447
View directory record Official record
Conditions
Glioblastoma
Interventions
Temozolomide, Lomustine, Regorafenib, Radiation, Paxalisib, VAL-083, VT1021, Troriluzole, ADI-PEG 20, AZD1390, Tinostamustine
Drug · Radiation · Biological
Lead sponsor
Global Coalition for Adaptive Research
Other
Eligibility
18 Years and older
Enrollment
2,250 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2030
U.S. locations
42
States / cities
Birmingham, Alabama • La Jolla, California • Los Angeles, California + 31 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Active, not recruiting Phase 1 Interventional

Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

NCT05001828
View directory record Official record
Conditions
Acute Myeloid Leukemia, Adult
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years to 99 Years
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
3
States / cities
Miami, Florida • Charlotte, North Carolina • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 20, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Terminated Phase 1Phase 2 Interventional

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers

NCT05616624
View directory record Official record
Conditions
Non Small Cell Lung Cancer, Non-small Cell Lung Cancer, Small-cell Lung Cancer, Small Cell Lung Carcinoma
Interventions
ADI-PEG 20, Gemcitabine, Docetaxel
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
3
States / cities
Chicago, Illinois • St Louis, Missouri • Fairfax, Virginia
Source: ClinicalTrials.gov public record
Updated Jul 26, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Recruiting Phase 1Phase 2 Interventional

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

NCT06085729
View directory record Official record
Conditions
Prostate Cancer
Interventions
ADI-PEG 20, Cabazitaxel, Carboplatin
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older · Male only
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

NCT01497925
View directory record Official record
Conditions
Solid Tumors, Prostate Cancer
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Sep 12, 2018 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 2 Interventional

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

NCT01910012
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 30, 2020 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 3 Interventional

Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy

NCT01287585
View directory record Official record
Conditions
Hepatocellular Carcinoma
Interventions
ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol), Placebo, Best Supportive Care
Drug · Other
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
636 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
21
States / cities
Birmingham, Alabama • Coronado, California • La Jolla, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2019 · Synced Sep 11, 2026, 5:23 PM EDT
Withdrawn Phase 2 Interventional

Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer

NCT04965714
View directory record Official record
Conditions
Resectable Hepatocellular Carcinoma
Interventions
Nivolumab, Pegargiminase, Resection
Biological · Procedure
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 15, 2023 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

NCT03922880
View directory record Official record
Conditions
Uveal Melanoma
Interventions
ADI PEG20, Nivolumab, Ipilimumab
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 14, 2025 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

NCT02101593
View directory record Official record
Conditions
Hepatocellular Carcinoma
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
2
States / cities
New York, New York • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Mar 3, 2016 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

NCT01948843
View directory record Official record
Conditions
HER2 Negative Metastatic Breast Cancer
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older · Female only
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 13, 2016 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

NCT02709512
View directory record Official record
Conditions
Mesothelioma
Interventions
ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum
Drug · Other
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
249 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
10
States / cities
Phoenix, Arizona • Los Angeles, California • San Francisco, California + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

ADI-PEG in Patients With Metastatic Melanoma

NCT00029900
View directory record Official record
Conditions
Melanoma, Neoplasm Metastasis
Interventions
ADI PEG
Drug
Lead sponsor
FDA Office of Orphan Products Development
Federal
Eligibility
Not listed
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2003
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Sep 11, 2026, 5:23 PM EDT
Terminated Phase 2 Interventional Results available

Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

NCT01266018
View directory record Official record
Conditions
Small Cell Lung Cancer
Interventions
ADI-PEG 20 (Arginine deiminase pegylated)
Drug
Lead sponsor
Ludwig Institute for Cancer Research
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
2
States / cities
New York, New York • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Oct 24, 2022 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1 Interventional

Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

NCT01665183
View directory record Official record
Conditions
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Interventions
ADI-PEG 20
Drug
Lead sponsor
Polaris Group
Industry
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 24, 2016 · Synced Sep 11, 2026, 5:23 PM EDT
Not yet recruiting Phase 1Phase 2 Interventional

Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)

NCT07389278
View directory record Official record
Conditions
Glioblastoma, High-Grade Glioma (WHO III-IV), High-grade Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Hemispheric Glioma, H3G34 Mutant
Interventions
ADI-PEG 20 (Arginine deiminase pegylated), Temozolomide (TMZ), Standard of Care Radiation Therapy (RT)
Drug · Radiation
Lead sponsor
Sabine Mueller, MD, PhD
Other
Eligibility
3 Years to 39 Years
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2035
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Sep 11, 2026, 5:23 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of ADI-PEG 20 in Patients With Advanced Melanoma

NCT00520299
View directory record Official record
Conditions
Metastatic Melanoma, Skin Cancer, Neoplasm
Interventions
ADI PEG 20
Drug
Lead sponsor
Ludwig Institute for Cancer Research
Other
Eligibility
18 Years and older
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
2
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 24, 2022 · Synced Sep 11, 2026, 5:23 PM EDT