Actively Recruiting
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
Led by Biotheryx, Inc. · Updated on 2025-06-06
82
Participants Needed
6
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic and/or locally advanced HR+/HER2- breast cancer
- For dose escalation: measurable disease and/or at least one lytic or mixed bone lesion assessable by CT or MRI, or non-measurable disease including bone lesions
- For dose expansion: measurable disease
- For dose escalation: received no more than 1 chemotherapy in metastatic/advanced setting
- For dose escalation: no limit on lines of endocrine therapy in metastatic setting
- For dose escalation: received CDK4/6 inhibitor therapy
- For dose expansion: received no more than 1 chemotherapy in metastatic/advanced setting
- For dose expansion: received no more than 2 lines of endocrine therapy and had prior endocrine therapy for at least 6 months before progression
- For dose expansion: received at most 2 lines of CDK4/6 inhibitor therapy and had prior CDK4/6 inhibitor therapy for at least 6 months
- Acceptable hematologic function with ANC ≥ 1500 per mL without growth-factors, platelet count ≥ 100,000 per mL without transfusions or thrombopoietic agents, and hemoglobin ≥ 9.0 g/dL with allowed packed red blood cell transfusion up to 14 days prior
- Acceptable liver function with bilirubin ≤ 2.0× institutional upper limit of normal (ULN) or < 3.0× ULN if Gilbert's disease, ALT/AST ≤ 3.0× ULN or ≤ 5.0× ULN if liver metastases, and alkaline phosphatase ≤ 2.5× ULN or ≤ 5.0× ULN if bone or liver metastases
- Able and willing to sign informed consent
- Meets all study requirements in the opinion of the Investigator
You will not qualify if you...
- RB1 (retinoblastoma) gene mutation
- Symptomatic visceral disease
- Clinical evidence or history of central nervous system metastasis
- Abnormalities in coagulation such as bleeding disorders or treatment with anticoagulants preventing injections of fulvestrant or luteinizing hormone-releasing hormone agonist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Biotheryx Investigative Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Biotheryx Investigative Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
3
Biotheryx Investigative Site
Houston, Texas, United States, 77030
Actively Recruiting
4
Biotheryx Investigative Site
San Antonio, Texas, United States, 78229
Actively Recruiting
5
Biotheryx Investigative Site
West Valley City, Utah, United States, 84119
Actively Recruiting
6
Biotheryx Investigative Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
D
Danette Powell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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