Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological … (NCT06977126) | Clinical Trial Compass
RecruitingPhase 1
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
Canada24 participantsStarted 2025-11-18
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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…