Study Of ATRN-119 In Patients With Advanced Solid Tumors
NCT ID: NCT04905914
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
132 participants
INTERVENTIONAL
2023-01-09
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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50mg ATRN-119
Once daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
100mg ATRN-119
Once daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
200mg ATRN-119
Once daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
350mg ATRN-119
Once daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
400mg ATRN-119
Twice daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
1100mg ATRN-119
Once daily oral administration
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
1300mg ATRN-119
Once daily oral administration
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
1500mg ATRN-119
Once daily oral administration
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
650mg ATRN-119
Twice daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
750mg ATRN-119
Twice daily oral administration.
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
550mg ATRN-119
Once or twice daily oral administration
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
800 mg ATRN-119
Once daily oral administration
ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
Interventions
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ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
Eligibility Criteria
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Inclusion Criteria
* Measurable disease defined by RECIST 1.1.
* Life expectancy ≥ 3 months.
* Subject must be capable of oral administration of study medication.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Aprea Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Crystal Miller, RN BSN
Role: STUDY_DIRECTOR
Aprea Therapeutics Inc
Locations
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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
Countries
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Other Identifiers
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AR-276-01
Identifier Type: -
Identifier Source: org_study_id
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