Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dinutuximab Beta · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Dinutuximab Beta + 13-cis-Retinoic Acid | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
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 a...
Dinutuximab Beta is being studied as maintenance therapy in people with high-risk neuroblastoma, a childhood cancer that arises from immature nerve cells. The clinical program has focused on Chinese participants with this condition. It is an investigational monoclonal antibody and is not described as approved for this use.
Dinutuximab Beta is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is the sponsor associated with the clinical evaluation of this monoclonal antibody in high-risk neuroblastoma.
Dinutuximab Beta is in Phase 1 clinical development. The single listed study, NCT05373901, is a Phase 1 evaluation of safety and pharmacokinetics as maintenance therapy in Chinese participants with high-risk neuroblastoma, and it is recorded as completed.
Dinutuximab Beta has been evaluated in one clinical trial, NCT05373901, titled Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma. It was a Phase 1, uncontrolled study that enrolled 8 participants in China and is now completed.
Dinutuximab Beta is a monoclonal antibody, a type of antibody-based therapy. It is designed to bind a specific molecular target, though the exact target is not specified here. Monoclonal antibodies generally work by recognizing and attaching to a chosen target on cells, which can direct immune activity toward those cells.