A Phase 1a/1b Study of the PI3Ka:RAS Breaker BBO-10203 in Subjects with Advanced SolidTumors (The BREAKER-101 Trial)

Contact:

NCT Number:

Protocol:

AAAV5636

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to find the best dose and effects of BBO-10203 when used alone or in combination with Trastuzumab in HER2-positive advanced breast cancer (aBC) or HR- positive, HER2-negative aBC or advanced non-small cell lung cancer (aNSCLC) with a KRAS (Kirsten rat sarcoma) mutation or advanced colorectal cancer (aCRC) with a KRAS mutation.BBO-10203 has not been approved by the Food and Drug Administration (FDA). Trastuzumab is FDA approved but not in combination with BBO-10203. This is a first in human study.

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years old or older - Must have minimum life expectancy of more than 12 weeks - Must be able to swallow tablets intact without chewing or crushing

Specialty Area(s)

Breast Cancer, Colon and Rectal Cancer, Lung cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032