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

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.

Trial Details

NCT ID
NCT06515470
Phase
PHASE1
Sponsor
Biotheryx, Inc.
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • BTX-9341
  • Fulvestrant
Locations (sample)
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • Houston, Texas, United States|29.76328,-95.36327
  • San Antonio, Texas, United States|29.42412,-98.49363
  • West Valley City, Utah, United States|40.69161,-112.00105

Key Eligibility Criteria

  • Metastatic and/or locally advanced HR+/HER2- breast cancer (dose escalation: measurable disease and/or at least 1 lytic or mixed \[lytic + scleroti…
  • Dose escalation: (a) received not more than 1 chemotherapy in the metastatic/advanced setting; (b) no limit to the lines of endocrine therapy (mono…
  • Dose expansion: (a) received not more than 1 chemotherapy in metastatic/advanced setting; (b) received not more than 2 lines of endocrine therapy (…
  • Acceptable hematologic function

For full eligibility, visit ClinicalTrials.gov.

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