A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects participating in this research study will receive BLU-222. There are 2 phases planned for the study. The first phase is called 'Phase 1', where different doses of BLU-222 will be given to subjects to identify the recommended dose. Phase 2 of the study will continue to test BLU- 222 taken alone and in combination with other available therapies at a selected dose based on what is learned in the first phase.

Are you Eligible? (Inclusion Criteria)

• Are you 18 years or older?
• Are you able to swallow oral medication whole?
• You do not have disease that is suitable for therapy administered with curative intent
• You do not have an active, uncontrolled infections (i.e but not limited to HBV, tuberculosis, hepatitis C)