Clinical Trial

Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Study acronym: DBPilot
Recruiting Phase 1
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Summary
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: • to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: * GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-07-02
Trial Details
NCT Number NCT06485947
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: EUSA Pharma, Inc.
Conditions Neuroblastoma
Enrollment 38 participants
Start Date 2025-01-28
Primary Completion 2030-07-01 (estimated)
Study Completion 2031-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-08