A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced and/or Metastatic Breast Cancer

Study Identifier:
BTX-9341-101
CT.gov Identifier:
NCT06515470
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

To evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of BTX-9341 in patients with advanced and/or metastatic HR+/HER2- breast cancer who received prior CDK4/6 inhibitor therapy and have no mutations in RB.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: BTX-9341 (Part A)
    • Read More
  • Drug: Experimental: BTX-9341 + fulvestrant (Part A)
  • Drug: Drug: Fulvestrant
  • Drug: Experimental: BTX-9341 + fulvestrant (Part B)
  • Drug: Other Names:
  • Drug: Patients will receive monotherapy administration of BTX-9341 and combination dose expansion combining BTX-9341 with fulvestrant.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * 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
    • 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
    • * 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START New Jersey
    East Brunswick, NJ, United States, 08816
    Investigator
    Bruno Fang
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Location
    START Los Angeles
    Los Angeles, CA, United States, 90025
    Investigator
    Lasika Seneviratne
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Breast Cancers