A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers

This study is testing a new oral medication called RGT-490 to see if it is safe and effective for treating certain advanced cancers. It specifically focuses on tumors that have a specific genetic change called a PIK3CA mutation, which helps doctors target the cancer more effectively.

This study is for adults with advanced or spreading cancers—including breast, uterine, or ovarian cancer—that have not responded to previous treatments. You must have the PIK3CA gene mutation, be generally active in your daily life, and have stable liver and kidney health.

As a participant, you will take the experimental pill RGT-490 while doctors monitor your health, how your body processes the drug, and how your tumor responds. You will have regular check-ups and scans to ensure the treatment is safe and to track any changes in your cancer.

This study is currently recruiting volunteers at medical centers in Los Angeles, California, and Houston, Texas. You can talk to your doctor to see if one of these locations is an option for you.