Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
NCT ID: NCT06515470
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
82 participants
INTERVENTIONAL
2024-07-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BTX-9341 (Part A)
BTX-9341 capsule(s) administered orally once daily (QD) in 28-day cycles
BTX-9341
Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable dose (MED) determined
BTX-9341 + fulvestrant (Part A)
BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days
BTX-9341
Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable dose (MED) determined
Fulvestrant
500 mg intramuscular injections on Day 15 and then every 28 days
BTX-9341 + fulvestrant (Part B)
BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days
Fulvestrant
500 mg intramuscular injections on Day 15 and then every 28 days
BTX-9341
Daily oral dose in 28-day cycles using dose determined in Part A
Interventions
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BTX-9341
Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable dose (MED) determined
Fulvestrant
500 mg intramuscular injections on Day 15 and then every 28 days
BTX-9341
Daily oral dose in 28-day cycles using dose determined in Part A
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1. ANC ≥ 1500 per mL. Note: Use of growth-factors to maintain the ANC criterion is prohibited.
2. Platelet count ≥ 100,000 per mL. Note: Use of transfusions or thrombopoietic agents to achieve the baseline platelet count criterion is prohibited.
3. Hemoglobin ≥ 9.0 g/dL. Note: Packed red blood cell transfusion is allowed up to 14 days prior to trial entry.
* Acceptable liver function
1. Bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (or \< 3.0 × institutional ULN if Gilbert's disease is present)
2. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × institutional ULN (≤ 5.0 × institutional ULN if liver metastases present)
3. 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biotheryx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Barton, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Biotheryx Investigative Site
Rochester, Minnesota, United States
Biotheryx Investigative Site
Omaha, Nebraska, United States
Biotheryx Investigative Site
Houston, Texas, United States
Biotheryx Investigative Site
San Antonio, Texas, United States
Biotheryx Investigative Site
West Valley City, Utah, United States
Biotheryx Investigative Site
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Biotheryx Investigative Site
Role: primary
Biotheryx Investigative Site
Role: primary
Biotheryx Investigative Site
Role: primary
Biotheryx Investigative Site
Role: primary
Biotheryx Investigative Site
Role: primary
Biotheryx Investigative Site
Role: primary
Other Identifiers
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BTX-9341-101
Identifier Type: -
Identifier Source: org_study_id
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