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
Renaissance Pharma Ltd.
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.
Description
This is a Phase 2/3, open label, single arm study, evaluating how well hu14.18K322A works and how safe it is in combination with chemotherapy, in relapsed and refractory high-risk neuroblastoma (HRNB) patients. The study is in 2 parts. The first part of the study will test two doses of hu14.18K322A to give with chemotherapy in 12 patients to confirm the best dose. Once the best dose is found, Part 2 of the study will recruit up to an additional 66 participants with relapsed disease and 66 participants with refractory disease. Children and young people who take part in the study must be betwe…
Eligibility
- Age range
- 1–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Are ≥18 months to \<18 years of age at time of informed consent or assent. 2. Are initially diagnosed with histologically proven HRNB with metastatic disease. 3. Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC) 4. Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for \>16 years). 5. Have recovered from the toxic effects of prior chemotherapies 6. Are at least 2 weeks beyond any major tumor surgery 7. Meet the following organ function criteria, as measured within 1 week prior to Investig…
Interventions
- Drughu1418K322A + Temozolomide + Irinotecan
21-day cycle for a maximum of 12 cycles
Locations (2)
- Children's Hospital Colorado Anschutz MedicalAurora, Colorado
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania