Status:
ACTIVE_NOT_RECRUITING
Study Of ATRN-119 In Patients With Advanced Solid Tumors
Lead Sponsor:
Aprea Therapeutics
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04905914
Start Date
January 9 2023
End Date
February 1 2028
Last Update
October 29 2025
Active Locations (7)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
2
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States, 44106
3
Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
4
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230