6 completed, 2 terminated. 5 Phase 1, 4 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency Pegzilarginase - Arginase I Deficiency, Hyperargininemia | Phase 3 | Terminated | Aeglea Biotherapeutics | 3 | 2023-04-04 | 2023-07-27 |
| A Multiple Ascending Dose Study of ACN00177 (Pegtarviliase) in Subjects With CBS Deficiency Pegtarviliase IV, Pegtarviliase SC - Homocystinuria Due to Cystathionine Beta-Synthase Deficiency | Phase 1 / Phase 2 | Terminated | Aeglea Biotherapeutics | 13 | 2021-05-13 | 2023-07-27 |
| Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency Pegzilarginase, Placebo - Arginase I Deficiency, Hyperargininemia | Phase 3 | Completed | Immedica Pharma AB | 32 | 2019-05-01 | 2026-08-21 |
| Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer Pegzilarginase, Pembrolizumab - Small-cell Lung Cancer | Phase 1 / Phase 2 | Completed | Aeglea Biotherapeutics | 68 | 2017-12-21 | 2021-11-04 |
| A Study of AEB1102 (Pegzilarginase) in Patients With Arginase 1 Deficiency AEB1102 - Arginase I Deficiency, Hyperargininemia | Phase 2 | Completed | Immedica Pharma AB | 14 | 2017-12-07 | 2026-09-24 |
| A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS Co-ArgI-PEG modified human arginase I - Acute Myeloid Leukemia, Myelodysplastic Syndrome | Phase 1 | Completed | Immedica Pharma AB | 21 | 2016-08-15 | 2026-08-13 |
| A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency AEB1102 - Arginase I Deficiency, Hyperargininemia | Phase 1 / Phase 2 | Completed | Aeglea Biotherapeutics | 16 | 2016-06-01 | 2019-06-12 |
| A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors Co-ArgI-PEG - Advanced Cancers | Phase 1 | Completed | Immedica Pharma AB | 76 | 2015-10-22 | 2026-08-06 |
Hyperargininemia (4) · Homocystinuria (1) · Leukemia, Myeloid, Acute (1) · Myelodysplastic Syndromes (1) · Small Cell Lung Carcinoma (1)
pembrolizumab (1)
United States (7) · Canada (5) · United Kingdom (4) · Portugal (2) · Australia (1) · Austria (1) · France (1) · Germany (1) · Italy (1) · Puerto Rico (1)
Mattias Rudebeck, PhD MSc BMedSc (4) · Cortney Caudill (2) · Josie Gayton (2)
2019 (1)