Porphysome Nanoparticles for Gynecological Cancers

Overseen By Stephanie Lheureux, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Radiopharmaceuticals

Disqualifiers: Myelodysplastic syndrome, Leukemia, Porphyria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephanie Lheureux, MD

Principal Investigator

Princess Margaret Cancer Centre/University Health Network

Eligibility Criteria

This trial is for women over 18 with advanced gynecological cancers who have a life expectancy of more than 3 months and are in relatively good physical condition. They must not be pregnant, breastfeeding, or planning curative therapy and should agree to use two effective contraceptives. Participants need adequate organ function and cannot have certain medical conditions or recent investigational drug treatments.

Inclusion Criteria

I am a woman aged 18 or older.

Life expectancy of >3 months

I can perform daily activities with minimal assistance.

Exclusion Criteria

I have had my spleen removed.

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

Treatment with an investigational drug within 15 days prior to study registration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of 64Cu-PS with one dose of unlabelled PS by intravenous route on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and imaging assessments

1 year

Treatment Details

Interventions

• Porphysome Nanoparticles

Trial Overview The study tests PORPHYSOMES (PS) and Copper-64 labelled PORPHYSOMES (64Cu-PS), both nanoparticle suspensions used for PET/CT imaging in patients with metastatic gynecological tumors. It's an open-label, first-in-human trial that gradually increases doses to evaluate safety and effects.

Participant Groups

Group I: PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+