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.
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 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.