The key elements of the design are:

  • A molecular screening program conducted at the Garvan Institute of Medical Research, encompassing genomics and other molecular assays for therapeutic targets, to identify ‘actionable’ mutations
  • An overarching framework protocol for multiple, parallel, signal-seeking sub-studies.

The modular signal-seeking trial design is intended to expedite testing of novel therapeutic concepts, while maintaining rigorous evaluation of safety and efficacy.

Positive sub-studies are designed to support industry-sponsored formal phase 2 studies, with the goal to develop practice changing clinical trials, coordinated by the CTC.