An Open-Label, Multicenter, First-in-Human, Phase 1 Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1)

This study is testing a new experimental pill called BBI-940 to see how well it works at stopping breast cancer from growing. It is the first time this drug is being given to humans, and researchers are looking to see if it works better on its own or when paired with a standard hormone therapy drug.

This study is for adults with advanced breast cancer that has spread or is hard to treat with current methods. You must have already tried certain standard treatments, and your doctors will need to check your tumor's genetic profile and scan results to see if you are a good match.

Participants will take the new medication, either alone or with a common hormone treatment called fulvestrant. You will undergo regular check-ups, imaging scans, and blood tests so the research team can carefully monitor your health and how the cancer responds to the drug.

The study is currently recruiting volunteers at specific medical centers in Los Angeles, CA; Lake Success, NY; and Austin, TX. Because it is a Phase 1 study, the team focuses heavily on safety and finding the right dose for patients.