Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

This clinical trial is an adaptive phase I/II study of KESONOTIDE™, a novel hGIIA-vimentin inhibitor in participants with solid tumours. This is a multicentre, open-label Phase I/II clinical trial. Phase I part of the study is a classic 3+3 dose escalation to identify the Maximum Tolerated Dose, Recommended Phase 2 Dose and Optimal Biological Dose. In the Phase II study, participants will be given one of the two recommended dose levels. This may be as monotherapy or in combination with standard of care. The study treatment will be a 21-day treatment Cycle (once every 3 weeks) and KESONOTIDE™ will be orally administered. Study treatment will continue until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent, lost to follow-up or another discontinuation criterion. This trial will utilise an adaptive design which permits treatment arm modification or early stopping for efficacy or futility.