Sponsor: Clarity Pharmaceuticals Ltd
Sponsor Study ID: CL04
Study Title: 67Cu SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High Risk Neuroblastoma: A Multi center, Dose escalation, Open label, Non randomized, Phase 1 2a Theranostic Clinical Trial
CTO #: 103185
NCT Number: NCT04023331
Phase: I/II
Protocol Type: Treatment
Age Group: Children
Disease Sites: Other Digestive Organ
Study Objectives: This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase. Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 67Cu-SARTATE. Once either the MTD for a single administration of 67Cu-SARTATE is established, or Cohort 4 has been completed, the study will be expanded to enroll an additional 10 subjects who will receive up to 2 therapy cycles of 67Cu-SARTATE at the MTD dose level.