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Completed

NCT Number: NCT05373901

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

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

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Key information

Conditions

High-risk Neuroblastoma

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • Participants 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

Treatment and study plan

Dinutuximab Beta

Drug

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

Drug

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.

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 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 assessments.

  2. Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  3. Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  4. Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  5. Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  6. Half-Life (t1/2) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  7. Clearance (CL) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  8. Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

  9. Volume of Distribution at Steady State (Vss) of Dinutuximab Beta

    Time frame: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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