Study Evaluating hu14.18K322A Antibody With Chemotherapy for Children and Young People With High-Risk Neuroblastoma

What this Trial Is About

Neuroblastoma is the most common solid cancer found outside the brain in young children, primarily affecting those under 5 years old with an average diagnosis age of 2 years. This multinational Phase 23 study is evaluating the safety and effectiveness of the monoclonal anti-GD2 antibody hu14.18K322A daretabart combined with chemotherapy in children and young people with relapsed or refractory high-risk neuroblastoma that has spread to other parts of the body. The study has two parts Part 1 will test two doses of hu14.18K322A with chemotherapy in 12 patients to determine the best dose. Following this, Part 2 will enroll up to 132 additional participants divided equally between those with relapsed and refractory disease. Participants will receive up to 12 cycles of treatment using a 21-day cycle of hu14.18K322A combined with temozolomide and irinotecan chemotherapy. During the study, children and young people aged 18 months to 18 years will be closely monitored through assessments including evaluation of overall and metastatic response rates at the end of treatment up to 12 months. Long-term effects will be followed for up to 3 years after treatment. Researchers will also track survival, duration of response, progression-free survival, and event-free survival to understand treatment impact and safety over time.

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