Naxitamab
- Generic Name
- Naxitamab
- Brand Names
- Danyelza
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1879925-92-4
- Unique Ingredient Identifier
- 9K8GNJ2874
- Background
Naxitamab (humanized 3F8, hu3F8) is an IgG1 monoclonal antibody directed against the oncofetal differentiation antigen GD2 disialoganglioside. Normally expressed during fetal development and in mature neurons, pain fibers, and skin cells, GD2 constitutes a highly efficient target in the treatment of neuroblastoma - it is widely expressed across and within ne...
- Indication
Naxitamab-gqgk is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of patients 1 year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
- Associated Conditions
- High risk, refractory Neuroblastomas of the bone or bone marrow, High risk, relapsed Neuroblastomas of the bone or bone marrow
- Associated Therapies
- -
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
- First Posted Date
- 2024-08-07
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Giselle Sholler
- Target Recruit Count
- 98
- Registration Number
- NCT06540963
- Locations
- 🇺🇸
Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
- First Posted Date
- 2024-07-30
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 45
- Registration Number
- NCT06528496
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
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.
- Conditions
- First Posted Date
- 2023-09-21
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- SciClone Pharmaceuticals
- Target Recruit Count
- 62
- Registration Number
- NCT06047535
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
- First Posted Date
- 2023-08-01
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- Anna Raciborska
- Target Recruit Count
- 24
- Registration Number
- NCT05968768
- Locations
- 🇵🇱
Mother and Child Institute, Warsaw, Mazowian, Poland
🇵🇱Wroclaw Medical University, Wrocław, Poland
Quadruple Immunotherapy for Neuroblastoma
- First Posted Date
- 2023-03-06
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- Hong Kong Children's Hospital
- Target Recruit Count
- 29
- Registration Number
- NCT05754684
- Locations
- 🇭🇰
Hong Kong Children's Hospital, Hong Kong, Hong Kong
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
- First Posted Date
- 2022-08-05
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Giselle Sholler
- Target Recruit Count
- 76
- Registration Number
- NCT05489887
- Locations
- 🇺🇸
University of Alabama, Children's Alabama, Birmingham, Alabama, United States
🇺🇸Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸UCSF Benioff Children's Hospital Oakland-, Oakland, California, United States
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
- First Posted Date
- 2021-06-01
- Last Posted Date
- 2022-09-01
- Lead Sponsor
- Y-mAbs Therapeutics
- Registration Number
- NCT04909515
- Locations
- 🇷🇺
National Medical Research Center Pediatric Hematology, Oncology and Immunology n.a Dmitry Rogachev, Moscow, Russian Federation
🇸🇬ICON Cancer Centre Novena, Singapore, Singapore
🇷🇺Research Institute of Pediatric Oncology ad Hematology of N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.