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Phase I-II

A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors

  • Study HIC#:2000034200
  • Last Updated:11/21/2023

The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid tumors.

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    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    • DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period.
    • Measurable disease defined by RECIST 1.1.
    • Life expectancy ≥ 3 months.
    • Subject must be capable of oral administration of study medication.

    Exclusion Criteria:

    • Subject has had a cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks.
    • Surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119.
    • Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D6.
    • Known human immunodeficiency virus infection (HIV).
    • Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications.
    • Current or past diagnosis of leukemia within the past 5 years.
    • Prior radiotherapy at the target lesion unless there is evidence of disease progression.
    • Known CNS metastases or clinical evidence of CNS involvement that is not stable for previous 1 month by radiology documentation (magnetic resonance imaging [MRI] brain).
    • History of non-malignant gastronintestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.
    • Patient has uncontrolled hypertension at time of enrollment.
    • Complete left bundle branch block (LBBB), bifascicular block (right bundle branch block [RBBB] with either left anterior hemiblock or left posterior hemiblock).
    • Any clinically significant ST segment and/or T-wave abnormalities.
    • Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: