Study on BLU-222 for Advanced Solid Tumors

Inclusion Criteria

• Have advanced solid tumors that have not responded to standard treatments.
• Have hormone receptor-positive, HER2-negative breast cancer that has progressed after treatment with a CDK4/6 inhibitor.
• Have endometrial or gastric cancer that has worsened after at least two previous treatments, including one platinum-based therapy.
• Have ovarian cancer that is resistant to platinum treatments and has a specific genetic change (CCNE1 amplification) and has not responded to standard treatments.

Exclusion Criteria

• Have severe symptoms due to cancer spreading to organs or the brain.
• Have previously been treated with certain similar drugs, except in specific cases.
• Have cancer that has spread to the brain or spinal cord causing worsening symptoms or needing increasing steroid doses.
• Have a history of brain bleeding or bleeding disorders.
• Have active lung disease or inflammation caused by drugs or radiation.
• Have unresolved side effects from previous treatments that are more than mild.
• Have certain heart conditions or a family history of heart rhythm problems.
• Have uncontrolled heart disease or recent heart attack.
• Have had another cancer within the last two years, except for certain skin cancers.
• Have an active, uncontrolled infection, including tuberculosis, hepatitis, or COVID-19.
• Need to take medications or supplements that cannot be stopped before the study.
• Have planned major surgery soon after starting the study.
• Are unable or unwilling to follow the study schedule and procedures.
• Are a woman of childbearing potential not using effective birth control or a man not using effective birth control.
• Are pregnant.