First-in-Human Study of STX-478 Alone and with Other Cancer Treatments for Advanced Solid Tumors

Inclusion Criteria

• Have an advanced solid tumor that cannot be removed by surgery and has spread or is locally advanced.
• Have a recent or new tumor sample available for testing.
• Have a tumor with a specific PI3Kα mutation.
• Be 18 years or older.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

• Have had a different type of cancer within the last 2 years.
• Have cancer that has spread to the brain or spine and is causing symptoms.
• Have a tumor with certain other genetic mutations.
• Have uncontrolled diabetes or type 1 diabetes.
• Have previously been treated with certain cancer drugs, except in specific cases.
• Have received any cancer treatment within 14 days or longer, depending on the drug's half-life, before starting the study treatment.
• Have side effects from previous cancer treatments that have not improved, except for hair loss and nerve damage.
• Have had radiation therapy within 14 days before starting the study treatment.
• For certain study groups, have had previous treatments for metastatic breast cancer or specific hormone therapies, unless used as part of early treatment.