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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Biotheryx, Inc.

Last updated on ClinicalTrials.gov

June 6, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites