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

BeiGene

Status and phase: Completed; Phase 1

Conditions: High-risk Neuroblastoma

Treatments: Drug: Dinutuximab Beta; Drug: 13-cis-Retinoic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05373901

BGB-dinutuximab beta-101

CTR20221154 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Dinutuximab Beta + 13-cis-Retinoic Acid

Experimental group

Description:

The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).

Treatment:

Drug: 13-cis-Retinoic Acid

Drug: Dinutuximab Beta