Actively Recruiting
First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers
Led by University Health Network, Toronto · Updated on 2026-01-08
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 PET/CT 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.
CONDITIONS
Brief Title
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients age 65 18 years.
- Life expectancy of >3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 64 2.
- Histologically confirmed metastatic advanced gynecological cancer of any epithelial subtype.
- Patients receiving standard chemotherapy and/or radiation treatment are eligible.
- Ability to understand and willingness to sign informed consent.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and study procedures.
- Use of 2 highly effective forms of contraception during study treatment and for 12 months after last dose for patients of childbearing potential and their partners.
- Baseline corrected QT interval prolongation < 470 milliseconds.
- Adequate organ function within 8 days before enrollment.
You will not qualify if you...
- Candidates for therapy with curative intent.
- Contraindications to PET/CT imaging such as phobias or inability to lie still in supine position for at least 20 minutes.
- Receiving nuclear medicine scans with other radiopharmaceutical agents during the exclusion period.
- Known myelodysplastic syndrome or acute myeloid leukemia.
- Treatment with investigational drugs within 15 days prior to registration.
- Receiving chemotherapy and/or radiation within 2 weeks before and 28 days after study drug administration.
- History of allergic reactions to similar compounds used in the study.
- Active COVID-19 infection at registration.
- Severe acute or chronic medical or psychiatric conditions increasing risk or interfering with results.
- Uncontrolled illnesses such as active infections requiring IV antibiotics, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance.
- Pregnant or breastfeeding women.
- Unresolved toxicity > CTCAE grade 1 from previous anti-cancer therapies with exceptions.
- Retinopathy grade 65 2.
- Patients with porphyria.
- Patients who have undergone splenectomy.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive one dose of 64Cu-Porphysomes and one dose of unlabelled Porphysomes by intravenous (IV) route on Day 1.
1 visit (in-person)
Duration - 1 year
Participants are monitored for safety and effects including dose limiting toxicities and tissue distribution for up to 1 year after treatment.
Multiple visits during 1 year follow-up
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
S
Stephanie Lheureux, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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