Study Of ATRN-119 In Patients With Advanced Solid Tumors

A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: ATRN-119

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Crystal Miller, RN BSN; Phone Number: 1 617 463 9385; Email: crystal.miller@aprea.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Yale Cancer Center
      • Principal Investigator: Patricia LoRusso, MD
      • Contact: Ingrid Palma
      • Contact: Email: Ingrid.palma@yale.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals, Cleveland Medical Center
      • Contact: Amit Mahipal, MD; Phone Number: 800-641-2422
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine
      • Contact: Fiona Simpkins, MD; Phone Number: 215-220-9519; Email: PerelmanGyn/OncResearchCoordinatorPool@uphs.upenn.edu
  • Texas
    • Dallas, Texas, United States, 75230
      • Active, not recruiting
      • Mary Crowley Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50mg ATRN-119; Once daily oral administration.	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.
Experimental: 100mg ATRN-119; Once daily oral administration.	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.
Experimental: 200mg ATRN-119; Once daily oral administration.	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.
Experimental: 350mg ATRN-119; Once daily oral administration.	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.
Experimental: 550mg ATRN-119; Once daily oral administration.	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.
Experimental: 800mg ATRN-119; Once daily oral administration.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aprea Therapeutics
• Investigators: Study Director: Crystal Miller, RN BSN, Aprea Therapeutics Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AR-276-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No