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| Diagnosis | High-Risk Neuroblastoma | Study Status | Open |
| Phase | II/III |
| Age | 18 Months to 18 Years | Randomisation | YES |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Drug: hu1418K322A + Temozolomide + Irinotecan (IV) |
| Last Posted Update | 2026-08-14 |
| ClinicalTrials.gov # | NCT07549321 |
International Sponsor
Renaissance Pharma Ltd.Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
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 of the body. This study aims to find out how effective and safe the treatment of an antibody called daretabart (hu14.18K322A) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.
Inclusion Criteria
- Patients must be between 18 months and 18 years of age.
- Patients must have newly diagnosed high-risk neuroblastoma that has spread to other parts of the body.
- Patients must have neuroblastoma that can be measured or monitored by the study team.
- Patients must be well enough to take part in the study and perform some normal daily activities.
- Must have recovered from the side effects of previous chemotherapy.
- Must be at least 2 weeks past any major tumor surgery.
- Must meet all blood and organ function requirements
- Patients who could become pregnant/father a child must have a negative pregnancy test and use effective birth control during the study and for 6 months after treatment ends.
- Patients must be willing to take part in all required study visits and procedures.
- Patients and/or their parent or legal guardian must provide consent
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
