Tests IR-101 in children with relapsed or refractory neuroblastoma
Tests the radiopharmaceutical IR-101 in young patients with neuroblastoma that returned or did not respond.
Plain-language title generated from the registry record
Registry title: Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Early phase 1
Where in China
- West China HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan University
- Trial code
- NCT07067346
- Record updated
- 29 July 2025
- Original description
Radiopharmaceutical in Relapsed/Refractory NeuroblastomaRead full original descriptionShow less
A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
Inclusion: Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC); All soft-tissue lesions detected on CT/MRI must be MIBG-avid; Age ≥12 months; Lansky performance status ≥50%; Adequate organ function and hematologic parameters.
Exclusion: Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；; Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration; Autologous transplant <12 weeks, or Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD); Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or >50% bone marrow) within 12 weeks prior to first dose of study drug; Renal Insufficiency; Active Infections.