Actively Recruiting
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Led by Renaissance Pharma Ltd. · Updated on 2026-05-01
144
Participants Needed
2
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are between 18 months and less than 18 years old at time of consent
- Have histologically proven high-risk neuroblastoma with metastatic disease
- Have measurable or evaluable disease as per International Neuroblastoma Response Criteria
- Have a Lansky performance status of 50 or higher (for ages 16 and under) or Karnofsky performance status of 50% or higher (for over 16 years old)
- Have recovered from toxic effects of prior chemotherapy treatments
- Are at least 2 weeks past any major tumor surgery
- Meet required organ function criteria measured within 1 week before study drug dosing including adequate bone marrow, kidney, liver, heart, lung, and central nervous system function
- If a woman of child-bearing potential, have a negative pregnancy test and agree to use effective contraception during and for 6 months after the study
- If a fertile male, agree to use condoms during the study and for 6 months after treatment
- Are willing and able to provide informed assent or consent as applicable
- Have a parent or legal guardian willing and able to provide informed consent if required
You will not qualify if you...
- Have any active uncontrolled infection or known HIV, hepatitis B, or hepatitis C infection
- Have any contraindications to study treatments
- Have grade 3 or higher diarrhea
- Have disease affecting major organ systems that limits ability to tolerate chemoimmunotherapy
- Have had allogeneic stem cell transplant within last 6 months or any solid organ transplant
- Are on hemodialysis
- Require systemic corticosteroids (except for allergic reactions) or other immunosuppressive medications
- Have taken enzyme-inducing anticonvulsants for at least 7 days before enrollment
- Have any malignancy other than neuroblastoma
- Have symptoms of congestive heart failure
- Have history of severe allergic reactions to anti-GD2 antibodies
- Are participating in another blinded or investigational drug study
- Are breastfeeding, pregnant, or unwilling to use effective birth control if of child-bearing potential
- Do not meet required washout periods from prior treatments before starting study drug
- Require medications interfering with study treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's Hospital Colorado Anschutz Medical
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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