Clinical Trial Finder

Inclusion Criteria:

• - Age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form.

• - Established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine.

• - Relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site.

• - Satisfactory performance status (>70 on the Lansky or Karnofsky scale) - Life expectancy >8 weeks.

Exclusion Criteria:

• - Indications for radiation therapy, surgical intervention for the primary disease at screening.

• - Isolated CNS relapse of neuroblastoma.

• - Planned use of any anticancer drugs concomitantly with BCD-245 in this clinical trial.

• - The need for continuous use of anticonvulsants.

• - Clinically significant neurological deficit or grade >2 peripheral neuropathy (CTCAE 5.0) - The need or probable need for systemic continuous use of glucocorticosteroids or other immunosuppressive drugs.

• - Signs of respiratory distress (dyspnea at rest and oxygen saturation <94% without oxygen supplementation) - Any severe organ dysfunction (> CTCAE 5.0 severity grade 2) at screening, except for hematological abnormalities.

• - Body weight less than 10 kg.

- Subject receiving anti-GD2 monoclonal antibody therapy within 6 weeks or less prior to intended study drug infusion

The study includes 2 stages: 1) Data collection and safety analysis for the first four subjects 12 years of age and older from Cohort 1 2) Data collection and analysis of safety, pharmacokinetics, pharmacodynamics and immunogenicity in all cohorts (Cohorts 1-4). The design of this Phase I study is based on standard 3 + 3 design approaches. Cohort 1 includes 4 subjects aged 12 years old and older, and 2 subjects aged 3 years old and older. Cohorts 2-4 include 3-6 subjects aged 3 years and older.

Arms

Experimental: Cohort 1

BCD-245 (anti-GD-2 monoclonal antibody), dose 1

Experimental: Cohort 2

BCD-245 (anti-GD-2 monoclonal antibody), dose 2

Experimental: Cohort 3

BCD-245 (anti-GD-2 monoclonal antibody), dose 3

Experimental: Cohort 4

BCD-245 (anti-GD-2 monoclonal antibody), dose 4

Interventions

Biological: - BCD-245

BCD-245 is administered as prolonged intravenous infusions during each cycle