Status:
COMPLETED
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
Lead Sponsor:
BeiGene
Conditions:
High-risk Neuroblastoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief 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 part...
Eligibility Criteria
Inclusion
- Signed informed consent form (ICF) and ability to comply with study requirements
- Age ≥ 12 months at consent
- Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Staging System (INSS) criteria.
- Participants who have previously received induction chemotherapy and achieved a partial or complete response followed by myeloablative therapy and stem cell transplantation. Stem cell transplantation should be completed within 120 days of dinutuximab beta first administration
- Exclusion Criteria:
- Hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins
- Actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study
- Previous treatment with anti-GD2 antibody before enrolling in this study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05373901
Start Date
June 7 2022
End Date
June 29 2023
Last Update
October 4 2024
Active Locations (3)
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1
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
2
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
3
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China