Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up Women only

Porphysome nanoparticle imaging for advanced gynecological cancers

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

Run by University Health Network, Toronto · NCT06977126 · Data updated 2026-11-12

This will test whether porphysome and copper-64–labelled porphysome nanoparticles can safely help image metastatic or advanced gynecological cancers with PET/CT scans in adults.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment24 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedNovember 18, 2025
Main results expectedNovember 18, 2026
Study endsNovember 19, 2027
Registry record updatedJanuary 8, 2026
Trial IDNCT06977126 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult women (≥18) with histologically confirmed metastatic or advanced epithelial gynecological cancers, ECOG 0–2, life expectancy >3 months, able to consent and attend visits are the intended participants.

Probably not a fit

Patients with early-stage disease, non-gynecological cancers, poor performance status (ECOG >2), short life expectancy (≤3 months), or contraindications such as prolonged QTc are unlikely to benefit from this imaging approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, first-in-human phase 1 dose-escalation trial administers escalating doses of pegylated porphyrin-lipid nanoparticles (porphysomes) and 64Cu-labelled porphysomes to adults with metastatic or advanced gynecological cancers. Participants undergo PET/CT imaging after dosing to describe biodistribution, tumor uptake, and safety. The study includes patients receiving standard oncologic treatments and enrolls those with ECOG performance status of 0–2 and a life expectancy greater than three months. Safety, tolerability, and imaging signal characteristics are the primary outcomes to guide dose selection for future work.

Why it matters

Potential benefit: If successful, these nanoparticles could produce clearer PET/CT images of gynecological cancer lesions and help doctors better locate disease.

How similar studies have gone: Preclinical studies of porphysomes have shown promising imaging results, but this is a first-in-human dose-escalation trial and clinical benefit has not yet been established.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

  • Principal investigator: Stephanie Lheureux, MD — Princess Margaret Cancer Centre/University Health Network
  • Study coordinator: Stephanie Lheureux, MD
  • Email: stephanie.lheureux@uhn.ca
  • Phone: 416-946-2818

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.