Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
NCT ID: NCT05782959
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2021-11-29
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
BCD-245 (anti-GD-2 monoclonal antibody), dose 1
BCD-245
BCD-245 is administered as prolonged intravenous infusions during each cycle
Cohort 2
BCD-245 (anti-GD-2 monoclonal antibody), dose 2
BCD-245
BCD-245 is administered as prolonged intravenous infusions during each cycle
Cohort 3
BCD-245 (anti-GD-2 monoclonal antibody), dose 3
BCD-245
BCD-245 is administered as prolonged intravenous infusions during each cycle
Cohort 4
BCD-245 (anti-GD-2 monoclonal antibody), dose 4
BCD-245
BCD-245 is administered as prolonged intravenous infusions during each cycle
Interventions
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BCD-245
BCD-245 is administered as prolonged intravenous infusions during each cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Locations
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Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, , Russia
Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow, , Russia
Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCD-245-1
Identifier Type: -
Identifier Source: org_study_id
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