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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecological Cancers
• Intervention / Treatment: Drug: PORPHYSOMES; Drug: 64Cu-PORPHYSOMES

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stephanie Lheureux, MD; Phone Number: 416-946-2818; Email: stephanie.lheureux@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
      • Principal Investigator: Stephanie Lheureux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients age ≥ 18 years.
• Life expectancy of >3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of care oncological treatment (i.e. chemotherapy and/or radiation) will be included.
• Patient is able to understand and is willing to sign a written informed consent document prior to registration/enrollment on to study.
• Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
• Patients of childbearing potential (as assessed by their local Investigator) and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception throughout the period of study treatment and for 12 months after last dose of study drug.
• Baseline corrected QT (QTc) interval prolongation < 470 milliseconds.
• Within 8 days of the proposed enrollment patients must have adequate organ function.

Exclusion Criteria:

• Patient is a candidate for therapy with curative intent.
• Patient has a contraindication to PET/CT imaging, including, but not limited to, phobias associated with imaging (e.g. claustrophobia) and those who cannot lie still in the supine position for at least 20 minutes.
• Patients receiving nuclear medicine scans with other radiopharmaceutical agents (ex: 18F-FDG or other) during the study's exclusionary period will be excluded from the study.
• Patients with known myelodysplastic syndrome/acute myeloid leukemia.
• Treatment with an investigational drug within 15 days prior to study registration.
• Patients must not receive any other oncological treatments, including chemotherapy and/or radiation, within 2 weeks before starting study drug administration (and for 28 days after study drug administration).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
• Patients with a known active COVID-19 infection at the time of registration/enrollment.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breast-feeding women.
• Unresolved toxicity > CTCAE grade 1 from previous anti-cancer therapies, including radiotherapy, with exception.
• Retinopathy ≥ grade 2.
• Patients with porphyria.
• Patients that have undergone a splenectomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS); Participants will receive one dose of 64Cu-PS with one dose of unlabelled PS (except for cohort 1) by intravenous (IV) route on Day 1.	Drug: PORPHYSOMES; Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension; Drug: 64Cu-PORPHYSOMES; Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose Limiting Toxicities (DLTs)	To determine the recommended dose of PORPHYSOME.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs	To evaluate the safety and tolerability of PS administration in subjects with advanced metastatic gynaecological cancers.	1 year
Tissue distribution and tumour uptake kinetics	To identify the tissue distribution and tumour uptake of escalating PS drug doses.	1 year
Concentration-time curves	To identify the plasma pharmacokinetic profiles of escalating PS drug doses.	1 year
Image- and model-based organ dosimetry	To estimate the radiation dosimetry of 64Cu-PS in healthy organ structures.	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Stephanie Lheureux, MD, Princess Margaret Cancer Centre/University Health Network

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 19, 2027

Study Registration Dates

• First Submitted: May 8, 2025
• First Submitted That Met QC Criteria: May 8, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OZUHN-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No