Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma

Launched by SICHUAN UNIVERSITY · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IR-101 for children with neuroblastoma, a type of cancer that has come back or has not responded to previous treatments. IR-101 is a special kind of medicine that delivers targeted radiation directly to cancer cells, aiming to attack the tumor while limiting harm to healthy tissue. The study is currently looking for participants who are at least one year old, have a high-risk form of neuroblastoma that shows up on specific scans, and are well enough to take part, with good organ function and activity levels.

If you join the trial, you can expect to receive this new treatment and be closely monitored to see how well it works and to check for any side effects. There are some important rules about who can join, such as not having had certain other cancer treatments recently or having active infections. This study is still in the early stages, so it’s focused on making sure the treatment is safe and determining the best dose. If you or your child fits the criteria and are interested, talking with your doctor can help you understand if this trial might be a good option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
• • 2. All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
• • 3. Age ≥12 months;
• • 4. Lansky performance status ≥50%;
• • 5. Adequate organ function and hematologic parameters;
• Exclusion Criteria:
• • 1. Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
• • 2. Treatment with \[¹³¹I\]MIBG or Lu-177 targeted radionuclide therapy \<3 months of last administration;
• • 3. Autologous transplant \<12 weeks, or Allogeneic transplant \<4 months (patients \>4 months post-transplant must be free of active GVHD);
• • 4. 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;
• • 5. Renal Insufficiency;
• • 6. Active Infections;