Overview

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

Status:
Not yet recruiting

Trial end date:
2024-01-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

BeiGene

Treatments:

Dinutuximab
Isotretinoin
Tretinoin

Criteria

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