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 an investigational therapy being studied as maintenance treatment for patients with high-risk neuroblastoma. It is being evaluated in a clinical trial in China for this indication. The drug is still in clinical development and has not been approved for use.
Dinutuximab Beta is being developed by BeOne Medicines Ltd., a company listed under the ticker ONC. The company is conducting clinical research on this drug for the treatment of high-risk neuroblastoma.
Dinutuximab Beta is in Phase 1 clinical development. A Phase 1 trial evaluating its safety and pharmacokinetics as maintenance therapy in Chinese participants with high-risk neuroblastoma has been completed. The drug remains investigational and is not yet approved.
Dinutuximab Beta has one completed clinical trial, NCT05373901, titled "Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma." This Phase 1 study enrolled 8 participants in China and was not randomized or blinded.
Dinutuximab Beta is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for high-risk neuroblastoma. The completed trial in China evaluated safety and pharmacokinetics, but the drug has not received regulatory approval.