First-in-Human Study of ODM-212 for Advanced Solid Tumors

Inclusion Criteria

• Adults aged 18 and older.
• Diagnosed with advanced solid tumors that cannot be cured with current treatments, including mesothelioma, certain types of lung, liver, and prostate cancers, among others.
• Need systemic treatment for cancer and have not responded to or cannot receive standard treatments.
• For Part 2: Must have measurable disease and provide a recent tumor sample.
• Good overall health with a performance status of 0 or 1.
• Life expectancy of more than 12 weeks.
• Willing to follow study procedures and provide informed consent.

Exclusion Criteria

• Active cancer within the last 2 years, except for certain skin or cervical cancers.
• Recent chemotherapy, immunotherapy, or radiation therapy.
• Brain metastases unless treated and stable.
• Active infections like HIV or hepatitis.
• Recent major surgery or inability to take oral medication.
• Use of other investigational drugs recently.
• Heart problems or other serious health conditions.
• Pregnant or breastfeeding women.
• Not using effective birth control if of childbearing potential.
• Kidney or liver impairment or abnormal blood tests.
• Any other major illness or condition that increases risk or affects participation.