Study Of ATRN-119 In Patients With Advanced Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT04905914
- Run by
- Aprea Therapeutics
- People needed
- 43
- Starts
- 2023-01-09
- Expected to finish
- 2026-03-09
- Last updated by the study team
- 2026-08-04
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Yale Cancer Center — New Haven, Connecticut, United States
- University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States
- Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- NEXT- Oncology Dallas — Irving, Texas, United States
- NEXT Oncology- San Antonio — San Antonio, Texas, United States
- NEXT Oncology- Virginia — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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