NCT04080024

A First-in-human Clinical Evaluation of SN132D in Patients With Breast and Pancreatic Cancer

A First-in-human Clinical Evaluation of the Novel Intravenous Contrast Agent SN132D in Patients With Breast and Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Spago Nanomedical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Conditions

• Breast Cancer
• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	SN132D	Novel manganese-based macromolecular MRI contrast agent

Timeline

• Start date: 2019-08-23
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2019-09-06
• Last updated: 2022-12-09

Locations

2 sites across 1 country: Sweden