drugset / Trial / NCT05373901
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk neuroblastoma
Timeline
- Start
- 2022-06-07
- Primary completion
- 2023-06-29
- Completion
- 2023-06-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 10 mg/m2 | Intravenous |
| Background | Isotretinoin | Other / unclassified | 160 mg/m2 | Oral |