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New treatment option for Breast Cancer
Official title Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07408089
What this study is testing
What is BBI-940?
BBI-940 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Adults with locally advanced or metastatic breast cancer, including estrogen receptor-positive/human epidermal growth factor receptor 2-negative...
- Prior treatment with standard therapies known to provide clinical benefit, appropriate for disease subtype and study part, including endocrine...
- 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)...
- Availability of archival or newly obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for protocol-specified biomarker analyses.
You likely can't join if
- 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.
See the full eligibility criteria
- Key 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Lake Success, New York, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Lake Success, New York, United States; Austin, Texas, United States; Dallas, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.