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Active, Not Recruiting

NCT Number: NCT04905914

Study Of ATRN-119 In Patients With Advanced Solid Tumors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATRN-119

Drug

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aprea Therapeutics

Industry

Registry information

Official study title

A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors

Acronym: ABOYA-119

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 28, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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