RecruitingPhase 1NCT07408089

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

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


Sponsor

Boundless Bio, Inc.

Enrollment

96 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called BBI-940, which works by breaking down a protein (kinesin) that cancer cells need to divide. It is being studied in adults with advanced or metastatic breast cancer — including hormone receptor-positive breast cancer and a specific type of triple-negative breast cancer. **You may be eligible if...** - You are an adult with locally advanced or metastatic breast cancer - You have hormone receptor-positive, HER2-negative (ER+/HER2-) disease that has been treated with endocrine therapy and a CDK4/6 inhibitor - Or you have triple-negative breast cancer of the luminal androgen receptor subtype (with androgen receptor expression of at least 10%) - Your cancer can be measured on imaging scans (per RECIST criteria) - You are in good enough health to take part (ECOG 0 or 1) - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have previously been treated with a kinesin inhibitor or degrader - You have a heart condition causing prolonged QT interval - You recently had a major blood clot in the lungs (within 6 weeks) - You are pregnant or breastfeeding - You have unresolved serious side effects from prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBBI-940

Oral small molecule degrader targeting Kinesin.

DRUGFulvestrant

Selective estrogen receptor degrader administered intramuscularly.


Locations(8)

The START Center for Cancer Research

Los Angeles, California, United States

The START Center for Cancer Research

Lake Success, New York, United States

NEXT Oncology

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

NEXT Oncology

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

The START Center for Cancer Care

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07408089


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