Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
Recruiting now · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06515470
- Run by
- Biotheryx, Inc.
- People needed
- 82
- Starts
- 2024-07-03
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Metastatic and/or locally advanced HR+/HER2- breast cancer (dose escalation: measurable disease and/or at least 1 lytic or mixed [lytic + sclerotic] bone lesion that can be assessed by CT or MRI or non-measurable disease [including bone lesions]; dose expansion: measurable disease)
- Dose escalation: (a) received not more than 1 chemotherapy in the metastatic/advanced setting; (b) no limit to the lines of endocrine therapy (monotherapy or combination therapy) in the metastatic setting; (c) received CDK4/6 inhibitor therapy
- Dose expansion: (a) received not more than 1 chemotherapy in metastatic/advanced setting; (b) received not more than 2 lines of endocrine therapy (monotherapy or combination therapy) and must have been on prior endocrine therapy for at least 6 months before progression; (c) received at most 2 lines of CDK4/6 inhibitor therapy (1 in the adjuvant setting and 1 in the metastatic setting) and must have been on prior CDK4/6 inhibitor therapy for at least 6 months
- Acceptable hematologic function
- ANC ≥ 1500 per mL. Note: Use of growth-factors to maintain the ANC criterion is prohibited.
- Platelet count ≥ 100,000 per mL. Note: Use of transfusions or thrombopoietic agents to achieve the baseline platelet count criterion is prohibited.
- Hemoglobin ≥ 9.0 g/dL. Note: Packed red blood cell transfusion is allowed up to 14 days prior to trial entry.
- Acceptable liver function
- Bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (or < 3.0 × institutional ULN if Gilbert's disease is present)
- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × institutional ULN (≤ 5.0 × institutional ULN if liver metastases present)
- Alkaline phosphatase ≤ 2.5 × institutional ULN (≤ 5.0 × institutional ULN if bone or liver metastases present)
- Able and willing to sign informed consent
- Meets all study requirements in the opinion of the Investigator
You may not qualify if…
- RB1 (retinoblastoma) gene mutation
- Symptomatic visceral disease
- Clinical evidence or history of central nervous system metastasis
- Abnormalities in coagulation, such as bleeding diathesis, or treatment with anticoagulants precluding injections of fulvestrant or luteinizing hormone-releasing hormone (LHRH) agonist
Where it is running
- Biotheryx Investigative Site — Rochester, Minnesota, United States (enrolling)
- Biotheryx Investigative Site — Omaha, Nebraska, United States (enrolling)
- Biotheryx Investigative Site — Houston, Texas, United States (enrolling)
- Biotheryx Investigative Site — San Antonio, Texas, United States (enrolling)
- Biotheryx Investigative Site — West Valley City, Utah, United States (enrolling)
- Biotheryx Investigative Site — Fairfax, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.