NCT06977126

Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers

First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, first-in-human, dose escalation study evaluating investigational drug PORPHYSOSMES (PS, pegylated porphyrin-lipid conjugate-containing nanoparticle suspension) and 64Cu-PORPHYSOMES (64Cu-PS, pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension) for PET/CT imaging assessments in patients with metastatic/advanced gynecological tumors.

Conditions

• Gynecological Cancers

Interventions

Type	Name	Description
DRUG	PORPHYSOMES	Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension
DRUG	64Cu-PORPHYSOMES	Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension

Timeline

• Start date: 2025-11-18
• Primary completion: 2026-11-18
• Completion: 2027-11-19
• First posted: 2025-05-18
• Last updated: 2026-01-08

Locations

1 site across 1 country: Canada