Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boundless Bio, Inc.
Study ID
NCT07408089
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBI-940 — DRUG
    Oral small molecule degrader targeting Kinesin.
  • Fulvestrant — DRUG
    Selective estrogen receptor degrader administered intramuscularly.

Study Details

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.

Key Dates

Start date
Feb 25, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
May 31, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Parts 1A, 1B. BBI-940 Monotherapy Escalation
    Participants receive BBI-940 given alone in multiple sequential dose escalation cohorts. BBI-940 is given orally in repeated 28-day cycles.
  • Experimental: Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation)
    Participants receive BBI-940 in combination with fulvestrant. BBI-940 is given orally in repeated 28-day cycles at one of multiple potential dose levels.
  • Experimental: Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification)
    Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles.
  • Experimental: Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR)
    Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles.

Primary Outcome Measure

Rate of dose limiting toxicities (DLTs) in each BBI-940 monotherapy dose escalation cohort. [ Time Frame: First 28 days of study treatment (through end of Cycle 1). ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
The START Center for Cancer ResearchLos AngelesCalifornia90025-
The START Center for Cancer ResearchLake SuccessNew York11042-
NEXT OncologyAustinTexas78758-
University of Texas Southwestern Medical CenterDallasTexas75390-
NEXT OncologyHoustonTexas77054-
NEXT OncologySan AntonioTexas78229-
The START Center for Cancer CareSan AntonioTexas78229-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The START Center for Cancer Research· Los Angeles, CAThe START Center for Cancer Research· Lake Success, NYNEXT Oncology· Austin, TXUniversity of Texas Southwestern Medical Center· Dallas, TXNEXT Oncology· Houston, TXNEXT Oncology· San Antonio, TX

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