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Study identifier: NCT06515470 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer

Condition: Breast Cancer  ·  Sponsor: Biotheryx, Inc.

PhasePhase 1
Planned participants82
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.

This description comes directly from the study's public registry record.

Talk to the study team

Danette Powell  ·  858-354-1814  ·  c-dpowell@biotheryx.com

Always discuss trial participation with your own doctor first.

Locations (6)

Biotheryx Investigative SiteRochester, Minnesota, United StatesRecruiting
Biotheryx Investigative SiteOmaha, Nebraska, United StatesRecruiting
Biotheryx Investigative SiteHouston, Texas, United StatesRecruiting
Biotheryx Investigative SiteSan Antonio, Texas, United StatesRecruiting
Biotheryx Investigative SiteWest Valley City, Utah, United StatesRecruiting
Biotheryx Investigative SiteFairfax, Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06515470