Study of ATRN-119 in Patients with Advanced Solid Tumors

Eligibility 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.
• * Patient 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.