96 Participants NeededMy employer runs this trial

BBI-940 + Fulvestrant for Breast Cancer

(KOMODO-1 Trial)

Recruiting at 7 trial locations
RR
AP
Overseen ByAngela Pietrofeso
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Boundless Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RC

Robert C. Doebele, MD, PhD

Principal Investigator

Boundless Bio, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have advanced breast cancer that is either ER+/HER2- or triple-negative with specific androgen receptor levels.
My cancer does not have the ESR1 mutation for Part 2A or it has FGFR1 amplification for Part 2B.
I can provide a tissue sample for testing.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • BBI-940
  • Fulvestrant

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Parts 1A, 1B. BBI-940 Monotherapy EscalationExperimental Treatment1 Intervention
Group II: Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR)Experimental Treatment1 Intervention
Group III: Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification)Experimental Treatment1 Intervention
Group IV: Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boundless Bio

Lead Sponsor

Trials
2
Recruited
190+

Boundless Bio, Inc.

Lead Sponsor