drugset / Trial / NCT06485947
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Phase 1
Recruiting
38 enrolled
Princess Maxima Center for Pediatric Oncology
EUSA Pharma, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-01-28
- Primary completion
- 2030-07-01
- Completion
- 2031-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 10 mg/m2 | — |