An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
Princess Maxima Center for Pediatric Oncology
22 participants
Nov 5, 2025
INTERVENTIONAL
Conditions
Summary
This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.
Eligibility
Inclusion Criteria3
- Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure
- Patients older than 1 year of age and not older than 18 years.
- Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations
Exclusion Criteria5
- Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy
- Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP.
- Breast feeding.
- Sexually active participants not willing to use highly effective contraceptive method (pearl index \<1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy.
- Patients that received prior treatment with chimeric antibodies.
Interventions
Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery. In phase Ib, using a 3+3 design, a dose escalation is performed to determine the RP2D.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07399821