A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients (NCT07549321) | Clinical Trial Compass
RecruitingPhase 2/3
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
United States144 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Months – 18 Years
SexALL
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Inclusion criteria
✓. Are ≥18 months to \<18 years of age at time of informed consent or assent.
✓. Are initially diagnosed with histologically proven HRNB with metastatic disease.
✓. Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)
✓. Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for \>16 years).
✓. Have recovered from the toxic effects of prior chemotherapies
✓. Are at least 2 weeks beyond any major tumor surgery
✓. Meet the following organ function criteria, as measured within 1 week prior to Investigational Medicinal Product (IMP) dosing:
✓. BM function: i. Platelets ≥50 × 109/L ii. Absolute neutrophil count (ANC) ≥0.50 × 109/L
Exclusion criteria
✕. Any active uncontrolled infection at the time of enrollment. Any known history of infection with human immunodeficiency virus (HIV), or active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
✕. Any contraindications to any of the study treatments.
✕. Patients with \>Grade 2 diarrhea.
✕. Patients with disease of any major organ system that would compromise their ability to withstand chemoimmunotherapy.
What they're measuring
1
Overall response rate (ORR)
Timeframe: Assessed at end of treatment (up to 12 months)
2
Metastatic complete response rate (mCRR)
Timeframe: Assessed at end of treatment (up to 12 months)
✕. Patients who have undergone a prior allogeneic stem cell transplant \< 6 months ago or have undergone a solid organ transplant.
✕. Patients who are on hemodialysis.
✕. Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study except to manage allergic reactions
✕. Patients on any other immunosuppressive medications