BiologicalDrug
Naxitamab clinical trials
Also written hu3F8 and Danyelza.
- studies test it
- 19
- open now
- 11
- in phase 3
- 0
- first study started
- 2011
Keep track of what changes. Save the naxitamab studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Name
Brand
Development codes
Other names
Combined with it in one product
Studies by the year they started
19 studies that test it; most in 2023 (3)
| Year | Studies |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
- Early Phase 1
- 1
- Phase 1
- 6
- Phase 2
- 14
- Phase 4
- 1
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 3 · Other 16
Memorial Sloan Kettering Cancer Center (7) · Y-mAbs Therapeutics (2) · Giselle Sholler (2) · SciClone Pharmaceuticals (1) · Anna Raciborska (1) · Shaare Zedek Medical Center (1) · Margaret Gatti-Mays (1) · Steven DuBois, MD (1)
Often tested with
Tested in the same studies.
Granulocyte-Macrophage Colony-Stimulating Factor (5) · Irinotecan (3) · Temozolomide (3) · Isotretinoin (2) · Tipifarnib (1) · Sargramostim (1) · Cyclophosphamide (1) · Topotecan (1)
Studies
Open first, then newest update. How each study uses naxitamab is read from its arms, and is right about nine times in ten.
Testing it · 19
- To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)RecruitingPhase 2Anna RaciborskaNCT05968768Written as Naxitamab
- Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5RecruitingPhase 2Shaare Zedek Medical CenterNCT07537400Written as Naxitamab
- Tipifarnib and Naxitamab for Relapsed/Refractory NeuroblastomaRecruitingPhase 2Giselle ShollerNCT06540963Written as Naxitamab
- N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With NeuroblastomaRecruitingPhase 2Memorial Sloan Kettering Cancer CenterNCT06528496Written as DANYELZA
- Naxitamab Added to Induction for Newly Diagnosed High-Risk NeuroblastomaRecruitingPhase 2Giselle ShollerNCT05489887Written as Naxitamab
- Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast CancerRecruitingPhase 1/2Margaret Gatti-MaysNCT06026657Written as Naxitamab
- Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory NeuroblastomaRecruitingPhase 1Steven DuBois, MDNCT07027748Written as Naxitamab
- Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)RecruitingPhase 1/2M.D. Anderson Cancer CenterNCT07011654Written as Naxitamab
- Quadruple Immunotherapy for NeuroblastomaRecruitingPhase 2Hong Kong Children's HospitalNCT05754684Written as Naxitamab
- Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed NeuroblastomaRecruitingPhase 2Sun Yat-sen UniversityNCT06013618Written as Naxitamab in combination therapy
- Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.Not yet recruitingPhase 4SciClone PharmaceuticalsNCT06047535Written as Naxitamab
- Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent OsteosarcomaActive, not recruitingPhase 2Memorial Sloan Kettering Cancer CenterNCT02502786Written as humanized anti-GD2 antibody
- Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone MarrowActive, not recruitingPhase 2Y-mAbs TherapeuticsNCT03363373Written as GM-CSF + Naxitamab
- Study of Chemoimmunotherapy for High-Risk NeuroblastomaActive, not recruitingEarly Phase 1Memorial Sloan Kettering Cancer CenterNCT03189706Written as Hu3F8
- Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk NeuroblastomaActive, not recruitingPhase 1/2Memorial Sloan Kettering Cancer CenterNCT01757626Written as Hu3F8 With GM-CSF
- A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk NeuroblastomaCompletedPhase 2Memorial Sloan Kettering Cancer CenterNCT03033303Written as Hu3F8
- Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk NeuroblastomaCompletedPhase 1Memorial Sloan Kettering Cancer CenterNCT02650648Written as hu3F8
- Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive TumorsCompletedPhase 1Memorial Sloan Kettering Cancer CenterNCT01419834Written as Humanized 3F8 Monoclonal Antibody (Hu3F8)
- Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.WithdrawnPhase 2Y-mAbs TherapeuticsNCT04909515Written as Naxitamab
Codes
What other systems call naxitamab · ClinicalTrials.gg INT001670
- MeSH (NLM) C000718263naxitamabOne source ClinicalTrials.gov
- UNII (FDA) 9K8GNJ2874NAXITAMABConfirmed FDA, Wikidata
- RxNorm 2474039One source FDA
- Wikidata Q103085694naxitamabConfirmed FDA, Wikidata
- NCI Thesaurus C123428NaxitamabOne source FDA
- DrugBank DB15965One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000718263 | naxitamab | One source ClinicalTrials.gov |
| UNII (FDA) | 9K8GNJ2874 | NAXITAMAB | Confirmed FDA, Wikidata |
| RxNorm | 2474039 | — | One source FDA |
| Wikidata | Q103085694 | naxitamab | Confirmed FDA, Wikidata |
| NCI Thesaurus | C123428 | Naxitamab | One source FDA |
| DrugBank | DB15965 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.