Back to resultsEvaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma
Primary Purpose
High-risk Neuroblastoma
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dinutuximab Beta
13 cis retinoic acid
Sponsored by
About this trial
This is an interventional treatment trial for High-risk Neuroblastoma
Eligibility Criteria
- 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.
- 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:
- 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
Sites / Locations
- Beijing Children's Hospital, Capital Medical University
- Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
- Tianjin Medical University Cancer Institute & Hospital
- The Children's Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dinutuximab beta cohort
Arm Description
Patients who received dinutuximab beta as maintenance therapy
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Area under the serum-concentration-time curve (AUC) of dinutuximab beta
Maximum observed serum concentration (Cmax) of dinutuximab beta
Minimum observed serum concentration (Cmin) of dinutuximab beta
Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta
Apparent terminal elimination half life (t1/2) of dinutuximab beta
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05373901
Brief Title
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Neuroblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dinutuximab beta cohort
Arm Type
Experimental
Arm Description
Patients who received dinutuximab beta as maintenance therapy
Intervention Type
Drug
Intervention Name(s)
Dinutuximab Beta
Intervention Description
Administered via intravenous infusion
Intervention Type
Drug
Intervention Name(s)
13 cis retinoic acid
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Up to 2 years
Title
Area under the serum-concentration-time curve (AUC) of dinutuximab beta
Time Frame
approximately 20 weeks
Title
Maximum observed serum concentration (Cmax) of dinutuximab beta
Time Frame
approximately 20 weeks
Title
Minimum observed serum concentration (Cmin) of dinutuximab beta
Time Frame
approximately 20 weeks
Title
Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta
Time Frame
approximately20 weeks
Title
Apparent terminal elimination half life (t1/2) of dinutuximab beta
Time Frame
approximately 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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:
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
Facility Information:
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Children's Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma
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