NCT04905914CompletedPhase 1/2
Study Of ATRN-119 In Patients With Advanced Solid Tumors
A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 17 May 2021
- Start date
- 9 Jan 2023
- Primary completion date
- 9 Mar 2026
- Lead sponsor
- Aprea Therapeutics
- Diseases
- Childhood cancers
- NCT number
- NCT04905914
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 43
- From 9 Jan 2023 to the primary completion date, 9 Mar 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications.
- 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).
- Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.
Other illness
- Known human immunodeficiency virus infection (HIV).
- 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.
Other
- Current or past diagnosis of leukemia within the past 5 years.
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Next Oncology Dallas Coordinator of this site? Confirm its status | Irving | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| NEXT Oncology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.