Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Start Date
2/25/2026
Completion Date
5/31/2029
Summary
This is a first-in-human, open-label, Phase 1 study evaluating BBI-940, an investigational kinesin oral molecular degrader, administered as monotherapy or in combination with fulvestrant in adults with advanced or metastatic breast cancer.
Detailed Description
The study consists of two parts: Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is a dose-escalation phase designed to evaluate the safety and tolerability of BBI-940 and to determine the recommended dose for expansion (RDE). Participants may have estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer or triple-negative breast cancer of the luminal androgen receptor subtype (TNBC-LAR). Part 2 is a dose-expansion phase designed to further evaluate BBI-940 at the selected RDE in defined participant populations. Part 2A evaluates BBI-940 in combination with fulvestrant, including multiple dose cohorts to evaluate the safety of the combination regimen and to determine the combination RDE in participants with ER+/HER2- breast cancer without an ESR1 mutation. Part 2B evaluates BBI-940 monotherapy at the RDE in participants with ER+/HER2- breast cancer with FGFR1 amplification. Part 2C evaluates BBI-940 monotherapy at the RDE in participants with TNBC-LAR. Across all parts of the study, treatment is administered in repeated 28-day cycles, and participants undergo protocol-specified safety assessments.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BBI-940
Fulvestrant
Conditions
Locations
The START Center for Cancer Research
Los Angeles, California 90025
United States
The START Center for Cancer Research
Lake Success, New York 11042
United States
NEXT Oncology
Austin, Texas 78758
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
NEXT Oncology
Houston, Texas 77054
United States
NEXT Oncology
San Antonio, Texas 78229
United States
The START Center for Cancer Care
San Antonio, Texas 78229
United States
NEXT Oncology
Fairfax, Virginia 22031
United States