Naxitamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | DANYELZA | — | 2020-11-25 | fda.gov ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03189706 | Jun 2017 → Jun 2027 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07027748 | Jun 2025 → Jul 2027 expected | neuroblastoma | Steven DuBois, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT02650648 | Jan 2016 → Jul 2025 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01662804 | Aug 2012 → May 2021 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01419834 | Aug 2011 → Aug 2023 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07011654 | Sep 2025 → Jul 2028 expected | triple-negative breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06026657 | Apr 2024 → Dec 2026 expected | Her2-receptor negative breast cancer | Margaret Gatti-Mays | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01757626 | Dec 2012 → Dec 2026 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07537400 | May 2026 → Jun 2028 expected | neuroblastoma | Shaare Zedek Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06540963 | Dec 2024 → Dec 2030 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 2 | NCT06528496 | Jul 2024 → Jul 2029 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05968768 | Oct 2023 → May 2027 expected | Ewing sarcoma | Anna Raciborska | Recruiting | No outcome recorded |
| Phase 2 | NCT06013618 | Jun 2023 → Dec 2026 expected | neuroblastoma | Sun Yat-sen University Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05489887 | Sep 2022 → Sep 2029 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 2 | NCT05754684 | Jan 2022 → Dec 2025 overdue | neuroblastoma | Hong Kong Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04909515 | Dec 2021 → Jun 2026 | neuroblastoma | Y-mAbs Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT04560166 | Nov 2021 → Sep 2022 | neuroblastoma | Y-mAbs Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT06438614 | Aug 2020 → Jul 2023 | neuroblastoma, soft tissue neoplasm | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 2 | NCT03363373 | Apr 2018 → Jun 2026 overdue | neuroblastoma | Y-mAbs Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03033303 | Jan 2017 → Sep 2025 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02502786 | Jul 2015 → Jul 2026 overdue | osteosarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06047535 | Oct 2023 → Jun 2027 expected | neuroblastoma | SciClone Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04501757 | — | neuroblastoma | Memorial Sloan Kettering Cancer Center | No longer available | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | naxitamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04501757 ↗ |
| Known as | DANYELZA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06528496 ↗ |
| Known as | hu3F8 | “The anti-GD2 monoclonal antibody Naxitamab (also known as hu3F8) in combination with macrophage colony-stimulating factor (GM-CSF) is currently under pivotal phase 3...” NCT06438614 ↗10“Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma” NCT02502786 ↗ “Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “The purpose of this study is to find out if "humanized 3F8" (Hu3F8) is safe for treating neuroblastoma and other cancers.” NCT01419834 ↗ “Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2” NCT03363373 ↗ |
| Known as | Humanized 3F8 | “The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for...” NCT01757626 ↗3“Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “The purpose of this study is to find out if "humanized 3F8" (Hu3F8) is safe for treating neuroblastoma and other cancers.” NCT01419834 ↗ “an antibody called Humanized 3F8 (Hu3F8)” NCT02502786 ↗ |
| Known as | Humanized 3F8 Monoclonal Antibody | “Humanized 3F8 Monoclonal Antibody (Hu3F8)” NCT01419834 ↗ |
| Known as | Monoclonal antibody hu3f8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297984 ↗ |
| Known as | Naxitamab gqgk | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297984 ↗ |
| Modality | Monoclonal antibody | “Humanized 3F8 Monoclonal Antibody (Hu3F8)” NCT01419834 ↗ |
| Route | Intravenous | “one cycle has 2 days of intravenous hu3F8 treatment” NCT01419834 ↗ |