Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer

Key Eligibility Requirements.

A participant must:

• Understand the trial procedures and agree to participate by giving written, signed, and dated informed consent (IC; or witness consent).
• Male or female participants ≥18 years old.
• Have a performance status of 0 or 1 on the ECOG performance scale.
• Participants must be willing and able to undergo a baseline tumour biopsy; for further information please refer to protocol.

• Participants must have a histologically or cytologically confirmed advanced solid malignancy and be refractory to or intolerant to established standard of care therapies known to provide clinical benefit as determined by the investigator.

• Participants must have measurable disease per RECIST v1.1, including at least one lesion that is measurable and appropriate for response evaluation. Lesions within a previously irradiated field are permissible as measurable disease provided that clear radiologic progression has been demonstrated and accurate measurement is feasible.

• Refer to the protocol for the full list of inclusion criteria

Exclusion criteria

• Received prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 21 days; or immunotherapy or definitive/curative intent radiation therapy within 28 days, before receiving their first dose of ODM-216.
• Have an autoimmune disease that has required systemic treatment in the past 2 years (i.e. use of disease modifying agents, high dose corticosteroids, or immunosuppressive drugs).
• Brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of trial treatment. These should be previously treated and shown to be stable for at least 3 months post treatment.
• Refer to the protocol for the full list of exclusion criteria