A Phase 1/2 Study of BBI-355 in People With Advanced Solid Tumors


Full Title

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications


The purpose of this study is to find the highest dose of BBI-355 to use safely in people with cancer. People in this study have solid tumors that have spread (metastasized) to other parts of the body. Their cancers also have “oncogene amplification.” This means the tumor has many copies of certain genes known to cause cancer. These genes are called oncogenes.

BBI-355 blocks a specific protein called Chk1, which helps cancer cells deal with stress. Cancer cells with oncogene amplification are thought to be under a lot of stress. Therefore, blocking Chk1 may cause cancer cells to stop growing or die. BBI-355 is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have breast cancer, esophageal cancer, ovarian cancer, head and neck cancer, non-small cell lung cancer, stomach cancer, uterine cancer, sarcoma, or another solid tumor.
  • Have cancer that has metastasized.
  • Have a tumor with oncogene amplification.
  • Have completed prior chemotherapy at least 4 weeks before getting BBI-355. At least 2 weeks must pass since finishing radiation therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please contact Dr. Alexander Drilon’s office at 646-608-3758.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID