drugset / Trial / NCT06977126

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

NCT06977126 ↗

Phase 1 Recruiting 24 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2025-11-18
Primary completion
2026-11-18
Completion
2027-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject 64Cu-PORPHYSOMES Diagnostic / imaging agent — Intravenous
Subject PORPHYSOMES Diagnostic / imaging agent — Intravenous