Phase 1 Study of Porphysome Nanoparticles for Imaging Safety and Distribution in Advanced Metastatic Gynecological Cancers

What this Trial Is About

Researchers are evaluating investigational drugs called PORPHYSOMES and 64Cu-PORPHYSOMES for imaging metastatic or advanced gynecological cancers. This first-in-human, open-label, dose escalation study aims to assess the safety, biodistribution, and imaging potential of these nanoparticle suspensions in patients with these cancer types. The study is sponsored by the University Health Network in Toronto and is classified as a Phase 1 trial. Participants will receive one dose of 64Cu-PS along with one dose of unlabelled PS by intravenous injection on Day 1, except for the first cohort who may receive only one of these. The study focuses on monitoring dose-limiting toxicities and adverse events over one year. It also evaluates how the drugs distribute in tissues, their uptake by tumors, concentration over time, and organ dosimetry through imaging and modeling. During the study, participants will undergo PETCT imaging assessments and various laboratory tests to monitor organ function and drug effects. Researchers will track safety outcomes and drug distribution for up to one year after dosing. Patients must attend scheduled visits and comply with study procedures, including contraception requirements for those of childbearing potential. The total duration of involvement includes screening, treatment, and follow-up periods spanning at least one year.

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