Actively Recruiting
A Phase 2/3 Study to Evaluate the Safety and Effectiveness of hu14.18K322A Combined With Chemotherapy in Children and Young People With High-Risk Neuroblastoma
Led by Renaissance Pharma Ltd. · Updated on 2026-05-01
144
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuroblastoma is the most common solid cancer outside the brain affecting young children, mainly those under 5 years old, with an average diagnosis age of 2 years. This study aims to evaluate how effective and safe the monoclonal antibody hu14.18K322A (daretabart) is when combined with chemotherapy for children and young people with high-risk neuroblastoma that has spread to other parts of the body. It is a Phase 2/3, open-label, single-arm trial focusing on relapsed and refractory high-risk neuroblastoma patients. The study has two parts: the first tests two doses of hu14.18K322A with chemotherapy in 12 patients to find the best dose. The second part will enroll up to 132 participants with relapsed or refractory disease. Treatment involves up to 12 cycles of a 21-day regimen combining hu14.18K322A, temozolomide, and irinotecan. After completing treatment, participants will be monitored for long-term effects. Participants will be children and young people aged between 18 months and 18 years with confirmed metastatic high-risk neuroblastoma. During the study, researchers will assess treatment response and safety through regular evaluations. Primary outcomes include overall response rate and metastatic complete response at the end of treatment. Secondary outcomes include overall survival, progression-free survival, and event-free survival, with follow-up extending up to three years after treatment.
CONDITIONS
Brief Title
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 months and under 18 years old at time of consent or assent
- Diagnosed with histologically confirmed high-risk neuroblastoma with metastatic disease
- Have measurable disease according to International Neuroblastoma Response Criteria
- Lansky performance status of 50 or higher (for ages 16 years and under) or Karnofsky performance status of 50% or higher (for over 16 years)
- Recovered from toxic effects of prior chemotherapy
- At least 2 weeks since any major tumor surgery
- Meet organ function requirements for bone marrow, kidney, liver, heart, lung, and central nervous system function
- For women of child-bearing potential, negative pregnancy tests and agreement to use effective contraception during the study and for 6 months after
- For fertile men, agreement to use condoms during the study and for 6 months after
- Willing and able to provide informed assent or consent as appropriate
- Parent or legal guardian willing and able to provide informed consent if applicable
You will not qualify if you...
- Active uncontrolled infection or known history of HIV, hepatitis B, or hepatitis C
- Contraindications to study treatments
- Grade 3 or higher diarrhea
- Disease affecting major organs that would prevent tolerating chemoimmunotherapy
- Prior allogeneic stem cell transplant within 6 months or solid organ transplant
- On hemodialysis
- Need for systemic corticosteroids or immunosuppressive medications during treatment (except for allergic reactions)
- Use of enzyme-inducing anticonvulsants within 7 days before enrollment
- Diagnosis of any cancer other than neuroblastoma
- Symptoms of congestive heart failure
- History of severe allergic reactions to anti-GD2 antibodies
- Participation in another blinded or investigational drug trial
- Pregnant, breastfeeding, or unwilling to use birth control if sexually active
- Not meeting required washout periods from prior therapies or medications
- Ongoing need for medications that may interfere with study treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 9 months (12 cycles of 21 days each)
Participants receive up to 12 cycles of hu14.18K322A combined with chemotherapy in 21-day cycles.
Visits every 21 days for up to 12 cycles
Duration - Up to 3 years
Participants are followed to study long-term effects after completing treatment.
Periodic follow-up visits during this time
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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