67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma

Neuroblastoma Clinical Trial

Official 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

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.

Clinical Trial Description

This is an 'adaptive trial'. The trial design uses the accumulating data from the ongoing trial to modify aspects of the trial (e.g. dose, number of treatments). The trial is also a 'personalised trial' as the interval between treatments and number of treatments is determined for each patient individually.

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 1 therapy cycle of 67Cu-SARTATE.

Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the International Neuroblastoma Response Criteria (INRC) guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).

Cohort expansion will commence once either the Maximum Tolerated Dose (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 at least 2 therapy cycles of 67Cu-SARTATE at the MTD dose level. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the INRC guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).

The study also includes a long-term follow-up period to 36 months following the first dose of 67Cu-SARTATE, although in person study visits are not required. ;

Related Conditions & MeSH terms

• Neuroblastoma
• Refractory Neuroblastoma
• Relapsed Neuroblastoma

• NCT number: NCT04023331
• Study type: Interventional
• Source: Clarity Pharmaceuticals Ltd
• Contact: Clarity Pharmaceuticals
• Phone: +61 (0) 2 9209 4037
• Email: clinicaltrials@claritypharmaceuticals.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 18, 2020
• Completion date: December 2028