Study on TAK-188 for Adults with Advanced or Spreading Solid Tumors

Inclusion Criteria

• Adults aged 18 or older.
• Good overall health with an ECOG performance status of 0 or 1.
• Must provide a recent biopsy sample or an archival sample if no new treatment was received before the biopsy.
• Adequate bone marrow, kidney, and liver function based on specific blood test results.
• Heart function must be sufficient, with a pumping ability above 50%.
• Recovery from previous treatment side effects to a mild level, except for certain conditions like hair loss or stable hormone replacement therapy.
• Women must be postmenopausal, surgically sterile, or agree to use two effective birth control methods during and after the study.
• Men must agree to use a condom or practice abstinence during and after the study.
• Must provide written consent to participate.
• Participants with controlled HIV are allowed if they meet specific health criteria.
• Must have certain types of advanced or metastatic solid tumors that have not responded to standard treatments.
• Must have measurable disease based on specific criteria.
• For certain cancer types, must have received prior specific treatments and meet additional criteria.

Exclusion Criteria

• Recent history of serious heart conditions or events.
• Prolonged QT interval on an ECG or history of certain heart rhythm disorders.
• Low oxygen levels in the blood.
• Recent treatment with other CCR8 targeting agents.
• Active lung conditions like pneumonitis or severe COPD.
• Known brain metastasis unless stable and treated.
• Recent serious infections or fever of malignant origin.
• Uncontrolled autoimmune diseases, except for certain stable conditions.
• Active hepatitis or other chronic infections.
• Recent major surgery or unresolved bleeding events.
• Concurrent cancer requiring active treatment, except for certain hormonal therapies.
• Recent treatment with certain investigational or anticancer therapies.
• Use of systemic corticosteroids or immunosuppressive therapy recently.
• Recent receipt of live vaccines.
• Recent stem cell or organ transplantation.
• Pregnant or breastfeeding women, unless breastfeeding is discontinued.
• Participants who are employees or family members of trial site staff.
• Participants considered vulnerable under local regulations.