A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Aprea Therapeutics
- Enrollment
- 43
- Locations
- 7
- Primary Endpoint
- Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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-
- •Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D
- •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.
Arms & Interventions
50mg ATRN-119
Once daily oral administration.
Intervention: ATRN-119 (Drug)
100mg ATRN-119
Once daily oral administration.
Intervention: ATRN-119 (Drug)
1100mg ATRN-119
Once daily oral administration
Intervention: ATRN-119 (Drug)
1300mg ATRN-119
Once daily oral administration
Intervention: ATRN-119 (Drug)
200mg ATRN-119
Once daily oral administration.
Intervention: ATRN-119 (Drug)
400mg ATRN-119
Twice daily oral administration.
Intervention: ATRN-119 (Drug)
650mg ATRN-119
Twice daily oral administration.
Intervention: ATRN-119 (Drug)
800 mg ATRN-119
Once daily oral administration
Intervention: ATRN-119 (Drug)
350mg ATRN-119
Once daily oral administration.
Intervention: ATRN-119 (Drug)
1500mg ATRN-119
Once daily oral administration
Intervention: ATRN-119 (Drug)
750mg ATRN-119
Twice daily oral administration.
Intervention: ATRN-119 (Drug)
550mg ATRN-119
Once or twice daily oral administration
Intervention: ATRN-119 (Drug)
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Time Frame: Day 1 to Day 28
Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed
Secondary Outcomes
No secondary outcomes reported