NCT07399821RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 5 Nov 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT07399821
- EU CT number
- 2023-507596-22-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 22
- From 5 Nov 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy
- 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.
Lab values
- 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.
Other
- Breast feeding.
Who the study is looking for
- 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
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prinses Máxima Centrum Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.