NCT07408089 Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
| NCT ID | NCT07408089 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boundless Bio, Inc. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2026-02-25 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Robert C. Doebele, MD, PhD
STUDY DIRECTOR
Boundless Bio, Inc.
Frequently Asked Questions
Who can join the NCT07408089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07408089 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07408089 currently recruiting?
Yes, NCT07408089 is actively recruiting participants. Contact the research team at clinicaltrials@boundlessbio.com for enrollment information.
Where is the NCT07408089 trial being conducted?
This trial is being conducted at Los Angeles, United States, Lake Success, United States, Austin, United States, Dallas, United States and 4 additional locations.
Who is sponsoring the NCT07408089 clinical trial?
NCT07408089 is sponsored by Boundless Bio, Inc.. The principal investigator is Robert C. Doebele, MD, PhD at Boundless Bio, Inc.. The trial plans to enroll 96 participants.
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