An Open-Label, Multicenter, First-in-Human, Phase I Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1)

Study Identifier:
BBI-940-101
CT.gov Identifier:
NCT07408089
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Key Inclusion Criteria
    • * Adults with locally advanced or metastatic breast cancer, including estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) disease or triple-negative breast cancer with luminal androgen receptor subtype (TNBC-LAR; androgen receptor expression ≥10% by immunohistochemistry), as applicable by 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.
    • * Measurable disease per RECIST v1.1, except for participants enrolled in Part 1A.
    • * Molecular eligibility as applicable by study part, including absence of an ESR1 mutation (Part 2A) or presence of FGFR1 amplification (Part 2B), based on prior local testing.
    • * Availability of archival or newly obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for protocol-specified biomarker analyses.
    • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • * Adequate hematologic, hepatic, renal, and coagulation function per protocol-defined laboratory criteria.
    • * Estimated life expectancy of at least 12 weeks.
    • * Ability to swallow oral medication and provide written informed consent.
    • Key
    Exclusion criteria
    • Prior exposure to an inhibitor or degrader of Kinesin.
    • * Known hypersensitivity to study intervention(s) or excipients.
    • * Receipt of recent anticancer therapy within protocol-defined washout periods.
    • * Other active malignancy likely to interfere with study assessment.
    • * Baseline QTcF >470 msec or congenital long QT syndrome.
    • * Clinically significant pulmonary embolism within 6 weeks prior to first dose.
    • * Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.
    • * Active infection requiring systemic therapy within 2 weeks prior to first dose.
    • * Pregnant or breastfeeding, or planning conception or gamete donation during the study or required post-treatment period.
    • * Prior solid organ transplant or allogeneic stem cell transplant with protocol-defined exceptions.
    • * Failure to recover to CTCAE Grade ≤1 (or baseline) from prior anticancer therapy, with protocol-specified exceptions.
    • * Any serious or uncontrolled medical, laboratory, or psychiatric condition that could compromise safety or study integrity.
    • * Other exclusion criteria as specified in the study protocol.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Muralidhar Beeram
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers