ODM-207 in Patients With Advance Solid Tumours

Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion

This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.

Inclusion Criteria:

• Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
• Life expectancy >12 weeks
• Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
• ECOG performance status of 0 to 1

Exclusion Criteria:

• History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
• Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
• History of or current leptomeningeal or brain metastasis or spinal cord compression.