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Naxitamab Clinical Trials

7 actively recruiting trials across 5 locations

▲ +1 trial since August 2026

Also known as: Anti-Gd2 IGG3 Monoclonal Antibody 3f8 Humanized, Danyelza, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Hu3F8, Humanized Anti-GD2 Antibody 3F8 +2 more

Pipeline

Phase 1: 1Phase 2: 4Phase 1/2: 2

Top Sponsors

  • Giselle Sholler2
  • Steven DuBois, MD1
  • Shaare Zedek Medical Center1
  • Margaret Gatti-Mays1
  • M.D. Anderson Cancer Center1

Indications

  • Cancer7
  • Neuroblastoma3
  • Breast Cancer2
  • Neuroblastoma Recurrent1
  • Anatomic Stage IV Breast Cancer AJCC v81

Other2 trials

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
Phase 2
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
Phase 2

Birmingham, Alabama1 trial

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

University of Alabama/Children's of Alabama

Phase 2

Little Rock, Arkansas1 trial

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Arkansas Children's Hospital

Phase 2

Boston, Massachusetts1 trial

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Boston Children's Hospital

Phase 1

Columbus, Ohio1 trial

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

Ohio State University Comprehensive Cancer Center

Phase 1/2

Houston, Texas1 trial

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

The University of Texas M. D. Anderson Cancer Center

Phase 1/2

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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