Study Of ATRN-119 In Patients With Advanced Solid Tumors

Sponsor: Aprea Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04905914

This Phase 1/2a open-label study evaluates the safety, pharmacokinetics, and preliminary efficacy of oral ATRN-119 in patients with advanced solid tumors. Eligible participants must have DDR mutations, measurable disease per RECIST 1.1, a life expectancy of at least 3 months, and the ability to take oral medication. ATRN-119 is administered in 50 mg and 200 mg HPMC capsules.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

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