Porphysome nanoparticle imaging for advanced gynecological cancers

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

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

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06977126 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Toronto, Ontario

• 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

Conditions Gynecological Cancers