Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Megadott ok: The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.
Key facts
- Where
- Austin, Dallas, Fairfax, Houston, Lake Success, Los Angeles és San Antonio, Egyesült ÁllamokSee the 8 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- NEXT OncologyAustin, Egyesült ÁllamokNo longer taking part
- University of Texas Southwestern Medical CenterDallas, Egyesült ÁllamokNo longer taking part
- NEXT OncologyFairfax, Egyesült ÁllamokNo longer taking part
- NEXT OncologyHouston, Egyesült ÁllamokNo longer taking part
- The START Center for Cancer ResearchLake Success, Egyesült ÁllamokNo longer taking part
- The START Center for Cancer ResearchLos Angeles, Egyesült ÁllamokNo longer taking part
- NEXT OncologySan Antonio, Egyesült ÁllamokNo longer taking part
- The START Center for Cancer CareSan Antonio, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Boundless Bio, Inc.
- Trial code
- NCT07408089
- Record updated
- 2026. augusztus 19.
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Prior exposure to an inhibitor or degrader of Kinesin; Receipt of recent anticancer therapy within protocol-defined washout periods; 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; 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; Known hypersensitivity to study intervention(s) or excipients; Other active malignancy likely to interfere with study assessment; Baseline QTcF >470 msec or congenital long QT syndrome; Any serious or uncontrolled medical, laboratory, or psychiatric condition that could compromise safety or study integrity; Pregnant or breastfeeding, or planning conception or gamete donation during the study or required post-treatment period; Other exclusion criteria as specified in the study protocol.