Study Of ATRN-119 In Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

— ABOYA-119  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905914
• Other study ID #: AR-276-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 9, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Aprea Therapeutics
• Contact: Crystal Miller, RN BSN
• Phone: 1 617 463 9385
• Email: crystal.miller[@]aprea.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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:

• Subject 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• ATRN-119
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.

Locations

Country	Name	City	State
United States	University Hospitals, Cleveland Medical Center	Cleveland	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Yale Cancer Center	New Haven	Connecticut
United States	Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aprea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics	Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed	Day 1 to Day 56