NCT04023331

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

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: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Clarity Pharmaceuticals Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 7 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) or the Maximum Feasible Dose (MFD) for a single administration of 67Cu-SARTATE is established, or Cohort 7 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/MFD 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.

Conditions

• Neuroblastoma
• Relapsed Neuroblastoma
• Refractory Neuroblastoma

Interventions

Type	Name	Description
DRUG	67Cu-SARTATE	67Cu-labelled MeCOSar-Tyr3-octreotate
DRUG	64Cu-SARTATE	64Cu-labelled MeCOSar-Tyr3-octreotate

Timeline

• Start date: 2020-08-18
• Primary completion: 2025-01-24
• Completion: 2025-03-25
• First posted: 2019-07-17
• Last updated: 2025-09-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study