NCT07408089 · Boundless Bio, Inc.
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
(KOMODO-1)
What this study is about
This is a first-in-human, where both patients and doctors know the treatment given, Phase 1 study evaluating BBI-940, an experimental kinesin taken by mouth molecular degrader, administered as treatment given alone or in combination with fulvestrant in adults with advanced or metastatic breast cancer.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
- Lake Success, New York
- Austin, Texas
- Dallas, Texas
- Houston, Texas
- San Antonio, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations