An Open-Label, Dose-Escalation, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-245 (JSC BIOCAD, Russia) Administered Intravenously to Subjects With Neuroblastoma

BCD-245-1

The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma.

2021-11-29

2023-06-01

2023-06-01

Recruiting

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-03-24