Clinical study BCD-245-1 will assess the key safety parameters after various single and multiple intravenous doses of BCD-245 in patients with relapsed or refractory neuroblastoma who have:
A diagnosis of neuroblastoma made on the basis of:
histological examination of the tumor tissue (with or without immunohistochemical examination) or
the presence of typical tumor agglomerates in the bone marrow and/or metaiodobenzylguanidine-accumulating lesion(s) and increased levels of catecholamine metabolites in the serum and/or urine.
Relapsed or refractory neuroblastoma resistant to anti-relapse therapy adopted at the study center.
Age 3 years or older.
Satisfactory overall condition (Lansky or Karnofsky score of >70).
This study uses exclusion criteria (criteria of ineligibility for the particular clinical study) a potential participant will be fully informed of by the study doctor. In particular, exclusion criteria include:
The BCD-245-1 study will be conducted at 3 study centers in Moscow and St. Petersburg.
If necessary, following agreement with the study doctor and consent of the clinical study participant or his/her legal representative, transportation services may be provided for trips required during the participation in this study. The study doctor will explain in detail the procedure of ordering transportation services to the clinical study participant or his/her legal representative.
When transportation services are ordered, no information about the clinical study participant or his/her legal representative will be displayed. collected, or transmitted to the Sponsor.
The study doctor will tell the potential participant (and/or his/her legal representative) about the other eligibility criteria and contraindications for participation in this clinical study. The potential participant (and/or his/her legal representative) must read the full information about the study and consult the study doctor and/or attending physician.