Phase 2 Naxitamab Neuroblastoma Trial, 10 Patients, Apr 17
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered Phase 2 trial NCT07537400 evaluating Naxitamab and GM-CSF chemoimmunotherapy combined with COG-type induction chemotherapy in 10 newly diagnosed high-risk neuroblastoma patients aged 12 months to 21 years. The trial aims to assess safety over approximately 2 years. This registration adds to the publicly available record of pediatric oncology clinical research.
What changed
NIH ClinicalTrials.gov registered a new Phase 2 clinical trial (NCT07537400) for Naxitamab, an investigational immunotherapy agent, in combination with GM-CSF for treatment of newly diagnosed high-risk neuroblastoma. The trial plans to enroll 10 patients between 12 months and 21 years of age receiving COG-type induction chemotherapy over 5 cycles. This is an informational registration entry documenting an active pediatric oncology study.
Affected parties including clinical investigators, research institutions, and sponsors should note this trial registration for protocol review, potential patient referrals, and competitive landscape awareness. Trial sponsors conducting similar neuroblastoma programs may find this registration relevant for development strategy considerations.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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 NCT07537400 Kind: PHASE2 Apr 17, 2026
Abstract
This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.
Conditions: High-Risk Neuroblastoma
Interventions: Naxitamab
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