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

Prior treatment

• 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;

Other illness

• Renal Insufficiency;
• Active Infections;

• 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;