VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS). Oncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues. VAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.
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Biodistribution and pharmacokinetics of the radiolabeled IMP
Timeframe: Day 1, 2, and 4 after dosing
Tumor-specific uptake of the IMP
Timeframe: Day 1 - 7 after dosing
Incidence of treatment emergent adverse events (AE) (safety and tolerability)
Timeframe: Study duration (up to 56 days)