MedTrace Logo

Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma

NCT07688252 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-07

No results posted yet for this study

Summary

This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells.

In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.

Conditions

  • High Risk Neuroblastoma

Interventions

BIOLOGICAL

Dinutuximab Beta

Dinutuximab-beta 10 mg/m²/day administered as a continuous intravenous infusion on Days 0-9 of Cycles 2-6.

DRUG

Induction chemotherapy

Six cycles of standard induction chemotherapy consisting of cyclophosphamide, vincristine, doxorubicin (or epirubicin), etoposide, and cisplatin administered according to the study treatment schedule.

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Shih-Hsiang Chen, M.D. · Chang Gung Memorial Hospital

  • Meng-Yao Lu, M.D. · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688252 on ClinicalTrials.gov