Study on ODM-212 for Adults with Advanced Solid Tumors

Inclusion Criteria

• Adults aged 18 and older.
• Good overall health with a performance status of 0 or 1 on a standard scale.
• Expected to live for more than 12 weeks, as assessed by the study doctor.
• Able to take oral medications and willing to keep a daily record of taking the study drug.
• Part 1: Participants with advanced or metastatic solid tumors who can receive one of the cancer treatments being studied.
  • Arm A: Advanced mesothelioma patients eligible for ipilimumab/nivolumab treatment.
  • Arm B: Metastatic pancreatic cancer patients eligible for nab-paclitaxel and gemcitabine treatment.
  • Arm C: Advanced NSCLC patients with a KRAS G12C mutation eligible for sotorasib treatment.
• Part 2: Participants must have measurable disease and provide a recent tumor sample.
  • Ipilimumab/nivolumab cohort: Advanced mesothelioma patients eligible for ipilimumab/nivolumab treatment.
  • Nab-paclitaxel/gemcitabine cohort: Metastatic pancreatic cancer patients eligible for nab-paclitaxel and gemcitabine treatment.
  • Sotorasib cohort, treatment naïve: Advanced NSCLC patients with a KRAS G12C mutation eligible for sotorasib treatment.
  • Sotorasib cohort, pretreated: Advanced NSCLC patients with a KRAS G12C mutation who have progressed on a prior KRAS G12C inhibitor.

Exclusion Criteria

• Active cancer within the last 2 years, except for certain skin cancers or carcinoma in situ.
• Recent chemotherapy, immunotherapy, or other cancer treatments within 2 weeks before starting the trial.
• Unresolved side effects from previous cancer treatments, except for certain conditions like controlled endocrine disorders.
• Recent radiation therapy within 4 weeks (definitive) or 2 weeks (palliative) before starting the trial.
• Brain or subdural metastases unless treated and stable.
• Severe active infection within 1 week of joining the trial.
• Positive tests for hepatitis B, hepatitis C, or HIV.
• Major surgery within 4 weeks or minor surgery within 1 week before starting the trial.
• Use of immunosuppressive medications within 2 days before starting the trial.
• Inability to take oral medication or have conditions affecting drug absorption.
• Use of other investigational drugs within 2 weeks or unresolved side effects from such treatments.
• Recent use of live vaccines within 28 days before starting the trial.
• Abnormal heart rhythms or conditions affecting heart function.
• Significant heart problems or recent heart events.
• Women who are pregnant or breastfeeding.