NCT05782959

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	BCD-245	BCD-245 is administered as prolonged intravenous infusions during each cycle

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

3 sites across 1 country: Russia