Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma

High-risk Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05373901
• Other study ID #: BGB-dinutuximab beta-101
• Secondary ID: CTR20221154
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: January 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study is for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese patients with high-risk neuroblastoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

1. Signed informed consent form (ICF) and ability to comply with study requirements

2. Age = 12 months at consent

3. Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Staging System (INSS) criteria.

4. Patients 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:

1. Hypersensitivity to = 1 component of dinutuximab beta antibody or against mouse proteins

2. Actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study

3. Previous treatment with anti-GD2 antibody before enrolling in this study

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• High-risk Neuroblastoma
• Neuroblastoma

Intervention

Drug:
• Dinutuximab Beta
Administered via intravenous infusion
• 13 cis retinoic acid
Administered orally

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	The Children's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 2 years
Primary	Area under the serum-concentration-time curve (AUC) of dinutuximab beta		approximately 20 weeks
Primary	Maximum observed serum concentration (Cmax) of dinutuximab beta		approximately 20 weeks
Primary	Minimum observed serum concentration (Cmin) of dinutuximab beta		approximately 20 weeks
Primary	Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta		approximately20 weeks
Primary	Apparent terminal elimination half life (t1/2) of dinutuximab beta		approximately 20 weeks