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OncoMatch/Clinical Trials/NCT07408089

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

Is NCT07408089 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BBI-940 and Fulvestrant for breast cancer.

Phase 1RecruitingBoundless Bio, Inc.NCT07408089Data as of May 2026

Treatment: BBI-940 · FulvestrantThis 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 wild-type

absence of an ESR1 mutation (Part 2A)

Required: FGFR1 amplification

presence of FGFR1 amplification (Part 2B)

Required: AR overexpression (≥10% by immunohistochemistry)

androgen receptor expression ≥10% by immunohistochemistry

Disease stage

Metastatic disease required

Measurable disease per RECIST v1.1, except for participants enrolled in Part 1A

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapies known to provide clinical benefit, appropriate for disease subtype and study part

Prior treatment with standard therapies known to provide clinical benefit, appropriate for disease subtype and study part, including endocrine therapy with CDK4/6 inhibition for ER+/HER2- disease

Cannot have received: Kinesin inhibitor or degrader

Prior exposure to an inhibitor or degrader of Kinesin

Lab requirements

Blood counts

adequate hematologic function per protocol-defined laboratory criteria

Kidney function

adequate renal function per protocol-defined laboratory criteria

Liver function

adequate hepatic function per protocol-defined laboratory criteria

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • NEXT Oncology · Austin, Texas
  • NEXT Oncology · Houston, Texas
  • NEXT Oncology · San Antonio, Texas
  • The START Center for Cancer Care · San Antonio, Texas
  • NEXT Oncology · Fairfax, Virginia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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