An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma

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 Criteria:

* 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 Criteria:

* 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.

Conditions2

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