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

BeiGene8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High-risk Neuroblastoma

Interventions

Dinutuximab BetaDRUG

Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2) per day for 10 consecutive days

13-cis-Retinoic AcidDRUG

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

Sex: ALLMin age: 12 Months

Medical Language ↔ Plain English

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. 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: 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

Locations (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

Outcomes

Primary Outcomes

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.

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

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