Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
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
1 other identifier
interventional
24
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 24, 2023
February 1, 2023
1.5 years
February 16, 2023
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Proportion of subjects with adverse reactions
52 weeks
Proportion of subjects with serious adverse reactions
52 weeks
Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0
52 weeks
Proportion of therapy discontinuations due to adverse reactions
up to 4 weeks
Secondary Outcomes (11)
Area under the plasma concentration versus time curve from time zero to t (AUC 0-t)
up to 4 weeks
Area under the plasma concentration versus time curve from zero to time infinity (AUC 0-∞)
up to 4 weeks
Peak plasma concentration (Cmax)
up to 4 weeks
Time of peak plasma concentration (Tmax)
up to 4 weeks
Half-life (T1/2)
up to 4 weeks
- +6 more secondary outcomes
Other Outcomes (5)
Overall response rate
52 weeks
Duration of response
52 weeks
Time to response
52 weeks
- +2 more other outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALBCD-245 (anti-GD-2 monoclonal antibody), dose 1
Cohort 2
EXPERIMENTALBCD-245 (anti-GD-2 monoclonal antibody), dose 2
Cohort 3
EXPERIMENTALBCD-245 (anti-GD-2 monoclonal antibody), dose 3
Cohort 4
EXPERIMENTALBCD-245 (anti-GD-2 monoclonal antibody), dose 4
Interventions
BCD-245 is administered as prolonged intravenous infusions during each cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 24, 2023
Study Start
November 29, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
March 24, 2023
Record last verified: 2023-02