RecruitingPhase 2Phase 3NCT07549321

A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients

A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination With Chemotherapy in Participants With High-Risk Neuroblastoma

Sponsor

Renaissance Pharma Ltd.

Enrollment

144 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

High Risk Neuroblastoma

Summary

Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites (metastases). This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.

Eligibility

Min Age: 18 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called hu1418K322A + Temozolomide + Irinotecan for people with high risk neuroblastoma. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Months to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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