ACTIVE_NOT_RECRUITING

Study Of ATRN-119 In Patients With Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-09

Study Completion:2028-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04905914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Crystal Miller, RN BSN

STUDY_DIRECTOR

Aprea Therapeutics Inc

Study Locations (Sites)

Yale Cancer Center

New Haven, Connecticut, 06520-8028

United States

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

NEXT- Oncology Dallas

Irving, Texas, 75039

United States

NEXT Oncology- San Antonio

San Antonio, Texas, 78229

United States

NEXT Oncology- Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Aprea Therapeutics

Crystal Miller, RN BSN, STUDY_DIRECTOR, Aprea Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-09

Study Completion Date2028-02

Study Record Updates

Study Start Date2023-01-09

Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor