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.
Single group
PORPHYSOMES
DrugPegylated porphyrin-lipid conjugate-containing nanoparticle suspension
64Cu-PORPHYSOMES
DrugPegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension
Incidence of Dose Limiting Toxicities (DLTs)
To determine the recommended dose of PORPHYSOME.
Incidence of AEs
To evaluate the safety and tolerability of PS administration in subjects with advanced metastatic gynaecological cancers.
Tissue distribution and tumour uptake kinetics
To identify the tissue distribution and tumour uptake of escalating PS drug doses.
Concentration-time curves
To identify the plasma pharmacokinetic profiles of escalating PS drug doses.
Image- and model-based organ dosimetry
To estimate the radiation dosimetry of 64Cu-PS in healthy organ structures.
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