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

NCT06977126 | Recruiting Phase 1 DMC

• 1 other identifier: OZUHN-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose Limiting Toxicities (DLTs)

  To determine the recommended dose of PORPHYSOME.

  1 year

Secondary Outcomes (4)

• Incidence of AEs

  1 year

• Tissue distribution and tumour uptake kinetics

  1 year

• Concentration-time curves

  1 year

• Image- and model-based organ dosimetry

  1 year

Study Arms (1)

PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS)

EXPERIMENTAL

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; Drug: 64Cu-PORPHYSOMES

Interventions

PORPHYSOMES DRUG

Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension

PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS)

64Cu-PORPHYSOMES DRUG

Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension

PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Study Officials

• Stephanie Lheureux, MD

  Princess Margaret Cancer Centre/University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lheureux, MD

CONTACT

416-946-2818; stephanie.lheureux@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 19, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)