Actively Recruiting
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Led by Boundless Bio, Inc. · Updated on 2026-04-13
96
Participants Needed
8
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced or metastatic breast cancer, including ER+/HER2- or TNBC-LAR subtype
- Prior treatments appropriate for disease subtype, including endocrine therapy with CDK4/6 inhibitors for ER+/HER2- disease
- Measurable disease per RECIST v1.1 (except Part 1A participants)
- Molecular eligibility by study part: absence of ESR1 mutation (Part 2A) or presence of FGFR1 amplification (Part 2B)
- Availability of archival or newly obtained tumor tissue suitable for biomarker analyses
- ECOG performance status of 0 or 1
- Adequate blood, liver, kidney, and coagulation function per protocol
- Estimated life expectancy of at least 12 weeks
- Ability to swallow oral medication and provide written informed consent
You will not qualify if you...
- Prior exposure to kinesin inhibitors or degraders
- Known allergy to study drugs or their ingredients
- Recent anticancer therapy within specified washout periods
- Another active cancer that may interfere with study assessments
- Baseline QTcF greater than 470 msec or congenital long QT syndrome
- Significant pulmonary embolism within 6 weeks before first dose
- Recent major surgery within 4 weeks or minor surgery within 2 weeks before first dose
- Active infection needing systemic treatment within 2 weeks before first dose
- Pregnant or breastfeeding, or planning pregnancy or gamete donation during study and follow-up
- Prior solid organ or allogeneic stem cell transplant with exceptions
- Incomplete recovery to Grade 1 or baseline from prior anticancer therapy
- Serious uncontrolled medical, laboratory, or psychiatric conditions that could affect safety or study integrity
- Other exclusion criteria as defined in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
The START Center for Cancer Research
Los Angeles, California, United States, 90025
Actively Recruiting
2
The START Center for Cancer Research
Lake Success, New York, United States, 11042
Actively Recruiting
3
NEXT Oncology
Austin, Texas, United States, 78758
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
NEXT Oncology
Houston, Texas, United States, 77054
Actively Recruiting
6
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
7
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
Actively Recruiting
8
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Angela Pietrofeso
CONTACT
R
Rebecca Reynolds
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here