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
2 other identifiers
interventional
8
1 country
3
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 participants with high-risk neuroblastoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 13, 2022
CompletedStudy Start
First participant enrolled
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2023
CompletedResults Posted
Study results publicly available
October 4, 2024
CompletedOctober 4, 2024
June 1, 2024
1.1 years
April 11, 2022
June 20, 2024
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (9)
Number of Participants With Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious treatment-emergent adverse event, characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, relationship to study treatment, and other safety assessments.
From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Half-Life (t1/2) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Clearance (CL) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Volume of Distribution at Steady State (Vss) of Dinutuximab Beta
From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Study Arms (1)
Dinutuximab Beta + 13-cis-Retinoic Acid
EXPERIMENTALThe study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Interventions
Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2) per day for 10 consecutive days
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.
Eligibility Criteria
You may not qualify if:
- Hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins
- Previous treatment with anti-GD2 antibody before enrolling in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (3)
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2022
First Posted
May 13, 2022
Study Start
June 7, 2022
Primary Completion
June 29, 2023
Study Completion
June 29, 2023
Last Updated
October 4, 2024
Results First Posted
October 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share