drugset / Trial / NCT07549321

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

NCT07549321

Phase 2/3 Recruiting 144 enrolled Renaissance Pharma Ltd.
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-30
Primary completion
2031-03
Completion
2031-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinutuximab Monoclonal antibody
Background Irinotecan Small molecule
Background Temozolomide Small molecule

Indications