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

Cannot have received: antibody-based immunotherapy

Exception: allowed if >5 half-lives or >30 days since last dose and recovered from adverse reactions

Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies

Cannot have received: targeted radionuclide therapy ([¹³¹I]MIBG, Lu-177)

Exception: allowed if ≥3 months since last administration

Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration

Cannot have received: autologous transplant

Exception: allowed if ≥12 weeks since transplant

Autologous transplant <12 weeks

Cannot have received: allogeneic transplant

Exception: allowed if ≥4 months since transplant and free of active GVHD

Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD)

Cannot have received: radiation therapy

Exception: allowed if >2 weeks since radiotherapy for non-sole lesion or if sole lesion has MIBG uptake after 2 weeks; extensive-field radiotherapy allowed if >12 weeks since prior to first dose

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