First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

This study is testing a new experimental drug called RLY-2608, which is designed to specifically target a common genetic change (the PIK3CA mutation) that helps cancer cells grow. By focusing on this specific mutation, researchers hope to create a more effective treatment option for patients with advanced solid tumors and certain types of breast cancer.

This trial is for adults with advanced solid tumors or HR+/HER2- breast cancer that has spread. You may be eligible if tests show your cancer carries a specific PIK3CA gene mutation and you meet certain requirements regarding your previous treatment history.

You will receive either the new drug alone or in combination with other established cancer therapies, depending on your specific diagnosis. The study team will monitor you closely to find the safest and most effective dose, which will involve regular check-ups, blood tests, and imaging scans to track your progress.

This study is currently recruiting patients at various locations across the United States, including sites in Arizona, California, and Colorado. Since this is an active trial, you should contact a study center near you to see if you qualify and if they are currently accepting new participants.