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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Dinutuximab beta cohort
    • Patients who received dinutuximab beta as maintenance therapy

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with adverse events (AEs)
    • Time Frame: Up to 2 years
    • 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
    • Time Frame: approximately 20 weeks
  • Maximum observed serum concentration (Cmax) of dinutuximab beta
    • Time Frame: approximately 20 weeks
  • Minimum observed serum concentration (Cmin) of dinutuximab beta
    • Time Frame: approximately 20 weeks
  • Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta
    • Time Frame: approximately20 weeks
  • Apparent terminal elimination half life (t1/2) of dinutuximab beta
    • Time Frame: approximately 20 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BeiGene
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • BeiGene, 1-877-828-5568, clinicaltrials@beigene.com

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