NCT05373901

Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma

An Open-Label, Multi-Center, Single-Arm, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-Risk Neuroblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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

Conditions

• High-risk Neuroblastoma

Interventions

Type	Name	Description
DRUG	Dinutuximab Beta	Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2) per day for 10 consecutive days
DRUG	13-cis-Retinoic Acid	13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.

Timeline

• Start date: 2022-06-07
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2022-05-13
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

3 sites across 1 country: China