A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RX108 in Patients with Advanced or Metastatic Solid Tumours.

This study will determine the safety and pharmacokinetics of the investigational drug RX108 in patients with advanced or metastatic solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with an incurable, locally advanced or metastatic solid tumour that has progressed or failed at least one prior systemic therapy or have refused systemic treatment. Study details All participants will receive the investigational drug RX108 through intravenous infusion at a low dose and will be escalated. Each participant will only receive a single dose, depending on the cohort into which they are recruited. The study will use an accelerated dose escalation design using single patient cohorts until a single related toxicity of Grade = 3 or a Dose Limiting Toxicity (DLT) is observed. Safety and tolerability of RX108 will be assessed by such as physical examination, vital signs, ECG, and clinical laboratory testing at 30 days and 7 months post intervention commencement. Maximum tolerated dose will be determined via the safety review committee (SRC) and Investigators review the optimal balance between the dose (pharmacokinetic (PK) parameters), toxicity and biomarker studies confirming target effect. Participants will be followed-up until 7 months post intervention commencement to investigate potential biomarkers for RX108.