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

Phase 1

Completed

• Conditions: High-risk Neuroblastoma
• Interventions: Drug: Dinutuximab Beta; Drug: 13-cis-Retinoic Acid

• Registration Number: NCT05373901
• Lead Sponsor: BeiGene

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-13
• Study Start: 2022-06-07
• Primary Completion: 2023-06-29
• Study Completion: 2023-06-29
• Status Verified: 2024-06
• Results First Submitted: 2024-06-20
• Results First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Results First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dinutuximab Beta + 13-cis-Retinoic Acid	Dinutuximab Beta	The 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).
Dinutuximab Beta + 13-cis-Retinoic Acid	13-cis-Retinoic Acid	The 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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month	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 asse...
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)

Trial Locations

Locations (3)

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine; 🇨🇳 Shanghai, Shanghai, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China

The Children's Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China