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Trial Title:
Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
NCT ID:
NCT05782959
Condition:
Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BCD-245
Description:
BCD-245 is administered as prolonged intravenous infusions during each cycle
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
3 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mikhail A Maschan
Phone:
+7 495 287 65 70
Email:
info@fnkc.ru
Facility:
Name:
Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Svetlana R Varfolomeev
Phone:
+7 (499) 324-24-24
Email:
info@ronc.ru
Facility:
Name:
Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ludmila S Zubarovskaya
Phone:
+7(812) 338 6265
Email:
bmt-director@1spbgmu.ru
Start date:
November 29, 2021
Completion date:
June 2023
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05782959
