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Study Of ATRN-119 In Patients With Advanced Solid Tumors
Trial Status: active
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.
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
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.
Additional locations may be listed on ClinicalTrials.gov for NCT04905914.
