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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension
Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGIncidence of Dose Limiting Toxicities (DLTs)
To determine the recommended dose of PORPHYSOME.
Time frame: 1 year
Incidence of AEs
To evaluate the safety and tolerability of PS administration in subjects with advanced metastatic gynaecological cancers.
Time frame: 1 year
Tissue distribution and tumour uptake kinetics
To identify the tissue distribution and tumour uptake of escalating PS drug doses.
Time frame: 1 year
Concentration-time curves
To identify the plasma pharmacokinetic profiles of escalating PS drug doses.
Time frame: 1 year
Image- and model-based organ dosimetry
To estimate the radiation dosimetry of 64Cu-PS in healthy organ structures.
Time frame: 1 year
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