An open-label, single-centre Phase I study of the safety and tolerability of PG545 in patients with advanced solid tumours

This study looks at the safety of using a drug called PG545 in determining its maximum tolerated dose in patients with advanced tumours. In this trial, PG545 will be used for the first time in humans. We will be looking at whether taking PG545 will results in changes to chemicals produced by the body which are linked to cancer growth and spread. Who is it for? You can join this study if you have any advanced (metastatic/widespread), non haematologic, malignant solid tumours, except for primary brain or spinal tumours. Trial details All participants in this study will be assigned to a cohort and will receive PG545 at 50-500 mg once weekly until either their disease progresses, they are removed from study due to a safety concern or the study reaches its end point (estimated to be 12 months). Patients will receive the same dose for the duration of the study. Follow up assessments to determine the optimum dose of PG545, its safety and tolerability, and pharmacokinetic / pharmacodynamic profiles will be measured at the end of the first treatment cycle (28 days) and continuously throughout the treatment duration. The aim of the study is to compare these outcomes amongst all participants, and to determine the possible side effects of PG545.