Study of hu14.18K322A for High-Risk Neuroblastoma
This study is looking at how safe and effective a treatment called hu14.18K322A (daretabart) is when given with chemotherapy (temozolomide and irinotecan) for children and young people with high-risk neuroblastoma. Neuroblastoma is a type of cancer that often affects young children. You may be able to join if you are between 18 months and 18 years old and have high-risk neuroblastoma that has spread. The study will measure how many patients respond to the treatment and how many have their metastatic (spread) disease completely cleared. The study is currently recruiting participants.
- Study design
- This is a Phase 2/3, open-label (everyone knows what treatment is being given), single-arm study. It plans to enroll up to 144 participants.
- What's involved
- Participants will receive treatment in 21-day cycles for up to 12 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed after treatment to study long-term effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
At a glance
Conditions
Where it's being run
6 sites across 6 statesWho to contact
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What this trial measures
- Overall response rate (ORR)Assessed at end of treatment (up to 12 months)
Proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve a complete response (CR) or partial response (PR) according to the International Neuroblastoma Response Criteria (INRC)
- Metastatic complete response rate (mCRR)Assessed at end of treatment (up to 12 months)
Proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve an overall metastatic complete response (mCR) response