TheranosticTrials.org

Clinical Trial · NCT07067346

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

Overview

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Sponsor

Sohag University

Phase

Early Phase 1

Contacts

Rong Tian, MD (CONTACT)

rongtiannuclear@126.com

18980601586

Rong Tian, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07067346

Eligibility

Inclusion

  • Lansky performance status ≥50%;
  • All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
  • Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
  • Adequate organ function and hematologic parameters;

Exclusion

  • Renal Insufficiency;
  • Autologous transplant \<12 weeks, or Allogeneic transplant \<4 months (patients \>4 months post-transplant must be free of active GVHD);
  • Active Infections;
  • 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;
  • 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;