This first-in-human Phase 1, multicentre, open label study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumours who failed standard of care therapies.~This Phase 1 study consists of 2 parts. The first part is a dose-escalation using a 3+3 design with up to 6 dose escalation cohorts at increasing levels. The dose-escalation part aims at determining the recommended clinical dose (RCD). The second part is an expansion at the RCD to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081.~Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended clinical dose (RCD) of DT-9081, followed by an expansion study of DT-9081 at RCD in participants with advanced, recurrent or metastatic solid tumours