Advanced Solid Tumor
Conditions
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 patients with advanced solid tumors.
Interventions
DRUGATRN-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.
Sponsors
Aprea Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3+3 Dose escalation design
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics | Day 1 to Day 28 | Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed |
Countries
United States
Contacts
STUDY_DIRECTORCrystal Miller, RN BSN
Aprea Therapeutics Inc
Outcome results
None listed