Overview
A Phase 1/2, Open-Label, First-in-Human Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumour Activity of ODM-216 in Participants With Advanced Solid Tumours
Eligibility
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.
6\. 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.
7\. 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.
8\. 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
