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

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.

NCT Number	NCT07549321
Lead Sponsor	Renaissance Pharma Ltd.
Conditions	High-Risk Neuroblastoma
Enrollment	144 participants
Start Date	2026-03-30
Primary Completion	2031-03 (estimated)
Study Completion	2031-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-14