11 recruiting, 4 active not recruiting, 3 completed, 1 not yet recruiting. 16 Phase 2, 5 Phase 1, 1 Early Phase 1, 1 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| 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 1-5 Naxitamab - High-Risk Neuroblastoma | Phase 2 | Recruiting | Shaare Zedek Medical Center | 10 | 2026-06-23 | 2026-09-17 |
| Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) Sacituzumab govitecan, Naxitamab - Metastatic Triple-Negative Breast Cancer | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 31 | 2025-09-19 | 2026-07-07 |
| Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma Naxitamab, Irinotecan, Temozolomide - Neuroblastoma, Neuroblastoma Recurrent | Phase 1 | Recruiting | Steven DuBois, MD | 18 | 2025-06-27 | 2026-07-14 |
| Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma Tipifarnib, Naxitamab - Neuroblastoma | Phase 2 | Recruiting | Giselle Sholler | 98 | 2024-12-06 | 2026-09-03 |
| N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma DANYELZA, Sargramostim, Cytoxan - High-risk Neuroblastoma, Neuroblastoma | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 45 | 2024-07-22 | 2026-08-28 |
| Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy - Neuroblastoma, GD2 Antibody (Naxitamab) | Recruiting | Guangzhou Women and Children's Medical Center | 64 | 2024-05-06 | 2024-08-28 | |
| 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 Cancer Biospecimen Collection, Computed Tomography, Gemcitabine - Anatomic Stage IV Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | Margaret Gatti-Mays | 42 | 2024-04-02 | 2026-07-23 |
| 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. Naxitamab - Neuroblastoma | Phase 4 | Not yet recruiting | SciClone Pharmaceuticals | 62 | 2023-10-31 | 2023-09-21 |
| To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) Naxitamab - Ewing Sarcoma | Phase 2 | Recruiting | Anna Raciborska | 24 | 2023-10-24 | 2026-10-07 |
| Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma Naxitamab monotherapy, GM-CSF, Irinotecan - Neuroblastoma | Phase 2 | Recruiting | Sun Yat-Sen University Cancer Center | 120 | 2023-06-19 | 2025-06-17 |
| Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma Naxitamab - Neuroblastoma | Phase 2 | Recruiting | Giselle Sholler | 93 | 2022-09-14 | 2026-08-12 |
| Quadruple Immunotherapy for Neuroblastoma Natural killer cell, Dinutuximab beta, Interleukin-2 - Neuroblastoma Recurrent | Phase 2 | Recruiting | Hong Kong Children's Hospital | 29 | 2022-01-01 | 2025-09-15 |
| Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. Naxitamab, GM-CSF, Isotretinoin - Neuroblastoma | Phase 2 | Withdrawn | Y-mAbs Therapeutics | 2021-12-02 | 2022-09-01 | |
| Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma Naxitamab and GM-CSF in combination with irinotecan and temozolomide - Neuroblastoma Recurrent | Phase 2 | Terminated | Y-mAbs Therapeutics | 2 | 2021-11-08 | 2024-03-18 |
| A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma HITS, Naxitamab + GM-CSF cycles, NICE - Refractory Neuroblastoma, Soft Tissue Cancer | Phase 2 | Completed | Fundació Sant Joan de Déu | 47 | 2020-08-20 | 2024-08-29 |
| Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow GM-CSF + Naxitamab - Neuroblastoma | Phase 2 | Active not recruiting | Y-mAbs Therapeutics | 122 | 2018-04-03 | 2026-07-30 |
| Study of Chemoimmunotherapy for High-Risk Neuroblastoma Irinotecan, temozolomide, Hu3F8 - Neuroblastoma (NB) | Early Phase 1 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 48 | 2017-06-12 | 2026-07-06 |
| A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma Hu3F8, GM-CSF, Isotretinoin - Neuroblastoma | Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 59 | 2017-01-23 | 2025-10-07 |
| Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma cyclophosphamide, NK cells, hu3F8 - Neuroblastoma, High-Risk | Phase 1 | Completed | Memorial Sloan Kettering Cancer Center | 85 | 2016-01-05 | 2025-07-30 |
| Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma humanized anti-GD2 antibody, GM-CSF - Recurrent Osteosarcoma | Phase 2 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 46 | 2015-07-01 | 2026-08-05 |
Showing 20 of 21. Sign in to see all of them.
Neuroblastoma (15) · Osteosarcoma (1) · Sarcoma (1) · Sarcoma, Ewing (1) · Triple Negative Breast Neoplasms (1)
Memorial Sloan Kettering Cancer Center (6) · Y-mAbs Therapeutics (3) · Giselle Sholler (2) · Anna Raciborska (1) · Fundació Sant Joan de Déu (1) · Guangzhou Women and Children's Medical Center (1) · Hong Kong Children's Hospital (1) · M.D. Anderson Cancer Center (1) · Margaret Gatti-Mays (1) · SciClone Pharmaceuticals (1) · Shaare Zedek Medical Center (1) · Steven DuBois, MD (1) · Sun Yat-Sen University Cancer Center (1)
United States (12) · Hong Kong (4) · Spain (3) · Canada (2) · China (2) · South Korea (2) · Brazil (1) · Denmark (1) · Germany (1) · India (1) · Israel (1) · Italy (1) · Poland (1) · Russia (1) · Singapore (1)
Brian Kushner, MD (2) · Shakeel Modak, MD (2) · Anna Raciborska, Prof. (1) · Brian H. Kushner, MD (1) · Clinton Yam, MD (1) · Daniel Cheuk (1) · Filemon Dela Cruz, MD (1) · Iris Fried, MD (1) · Jaqueline Kraveka, DO (1) · Margaret E Gatti-Mays, MD MPH (1) · Steven DuBois, MD, MS (1) · Valerie Brown, MD, PhD (1) · Yizhuo Zhang (1)
PMID 29147617, PMID 30326045, PMID 31401903, PMID 32733795, PMID 33572900, PMID 33844437, PMID 34885651, PMID 35327550, PMID 35681553, PMID 35880942, PMID 40067131, PMID 41299684, PMID 41670398