Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the UK / NCT03363373
Active, not recruiting Phase 2

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

NCT03363373 · tracked via the Priya Life Science UK tracker
Sponsor
Y-mAbs Therapeutics
Phase
Phase 2
Started
2018-04-03
Last updated
2026-07-30

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

GM-CSF + NaxitamabAll Gm-Csf trials (8) →All Naxitamab trials (5) →

GM-CSF + Naxitamab: Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody

Study summary

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose.

Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Eligibility

Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria * High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow. * Life expectancy ≥ 6 months Exclusion Criteria: * Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF * Evaluable neuroblastoma outside bone and bone marrow * Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function * Active life-threatening infection

Primary outcome measure(s)

  • Response rate during Naxitamab treatment — 101 weeks
    Overall objective response rate (ORR) during the Naxitamab treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions.

Trial sites (20)

FacilityCityRegionStatus
Riley Hospital for Children Indianapolis Indiana
Memorial Sloan Kettering Cancer Center New York New York
The Hospital for Sick Children Toronto Canada
Rigshospitalet Copenhagen Denmark
University Medical Center Hamburg-Eppendorf Hamburg Germany
Johannes Gutenberg-Universität Mainz Germany
University Hospital Regensburg Regensburg Germany
Hong Kong Children's Hospital Hong Kong Hong Kong
Queen Mary Hospital Hong Kong Hong Kong
Tata Memorial Centre Mumbai India
Giannina Gaslini Hospital Genoa Genoa
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Milan
Ospedale Pediatrico Bambino Gesù Rome Italy
Hospital Sant Joan de Déu Barcelona Spain
Hospital Infantil Universitario Niño Jesús Madrid Spain
Hospital Universitario Virgen Del Rocío Seville Spain
Hospital Universitario y Politécnico La Fe Valencia Spain
The Royal Glasgow Children's Hospital Glasgow United Kingdom
Leeds General Infirmary Leeds United Kingdom
University Hospital Southampton Southampton United Kingdom

Other trials for the same condition

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) Recruiting
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma Active, not recruiting
A Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03363373 on ClinicalTrials.gov ↗ ← All trials in the UK