RecruitingEarly Phase 1NCT07067346

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

A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma

Sponsor

Sichuan University

Enrollment

10 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Min Age: 12 Months

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;

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;