Study Of ATRN-119 In Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: ATRN-119

• Registration Number: NCT04905914
• Lead Sponsor: Aprea Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-28
• Study Start: 2023-01-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
50mg ATRN-119	ATRN-119	Once daily oral administration.
100mg ATRN-119	ATRN-119	Once daily oral administration.
200mg ATRN-119	ATRN-119	Once daily oral administration.
350mg ATRN-119	ATRN-119	Once daily oral administration.
400mg ATRN-119	ATRN-119	Twice daily oral administration.
1100mg ATRN-119	ATRN-119	Once daily oral administration
1300mg ATRN-119	ATRN-119	Once daily oral administration
1500mg ATRN-119	ATRN-119	Once daily oral administration
650mg ATRN-119	ATRN-119	Twice daily oral administration.
750mg ATRN-119	ATRN-119	Twice daily oral administration.
550mg ATRN-119	ATRN-119	Once or twice daily oral administration

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

University Hospitals, Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States