A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
ConditionHigh-Risk Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-18
SponsorRenaissance Pharma Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- hu1418K322A + Temozolomide + Irinotecan
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov