Clinical Trials
Sponsor:
Sponsor Study ID:
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
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.
Study Documents
(MUSC NetID required for document access)