12 Months and older, any sex, with High-risk Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs)Primary· From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
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.
Participants With At Least 1 TEAE
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
8
Participants with Serious TEAEs
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
1
Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
3956.3
± 33.11
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
4228.6
± 31.94
Maximum Observed Serum Concentration (Cmax) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
13.49
± 32.682
Time to Maximum Serum Concentration (Tmax) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
240.4
168 – 252
Half-Life (t1/2) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
253.9
200 – 332
Clearance (CL) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
17.19
± 34.627
Volume of Distribution During Terminal Phase (Vz) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
6295.9
± 48.87
Volume of Distribution at Steady State (Vss) of Dinutuximab BetaPrimary· From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)
Group
Value
95% CI
Dinutuximab Beta + 13-cis-Retinoic Acid
3594.0
± 37.12
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Other recruiting trials for High-risk Neuroblastoma
Currently open trials in the same condition.
NCT06831552 — Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
· NA
· recruiting
NCT06803875 — Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
· Phase 1, PHASE2
· recruiting
NCT06528496 — N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
· Phase 2
· recruiting
NCT06057948 — A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
· Phase 2
· recruiting
NCT05650749 — GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma
· Phase 1
· recruiting
Other BeiGene trials
Trials by the same sponsor.
NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob
· Phase 4
· recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum
· Phase 2
· active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-
· Phase 1
· active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
· Phase 1
· completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 4 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373901.