Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients 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

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

Study Overview

• Status: Completed
• Conditions: High-risk Neuroblastoma
• Intervention / Treatment: Drug: Dinutuximab Beta; Drug: 13 cis retinoic acid

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Children's Hospital, Capital Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Children's Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dinutuximab beta cohort; Patients who received dinutuximab beta as maintenance therapy	Drug: Dinutuximab Beta; Administered via intravenous infusion; Drug: 13 cis retinoic acid; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Area under the serum-concentration-time curve (AUC) of dinutuximab beta		approximately 20 weeks
Maximum observed serum concentration (Cmax) of dinutuximab beta		approximately 20 weeks
Minimum observed serum concentration (Cmin) of dinutuximab beta		approximately 20 weeks
Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta		approximately20 weeks
Apparent terminal elimination half life (t1/2) of dinutuximab beta		approximately 20 weeks

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Dinutuximab; Tretinoin; Isotretinoin
• Other Study ID Numbers: BGB-dinutuximab beta-101; CTR20221154 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No