Assessing ATRN-119 for 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

This study is testing a new oral medication called ATRN-119 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Aprea Therapeutics (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 7 sites (New Haven, Connecticut and 6 other locations)
• Trial ID: NCT04905914 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of ATRN-119, an oral medication, in patients with advanced solid tumors. It is designed as a Phase 1/2a, open-label trial that will assess pharmacokinetics and preliminary efficacy. Participants will be monitored for their response to the treatment and any potential side effects. The study aims to provide insights into the therapeutic potential of ATRN-119 for this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have documented DNA damage response mutations and can take oral medication.

Not a fit: Patients who have recently undergone chemotherapy, immunotherapy, or have active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While this approach is novel, similar studies targeting DNA damage response mutations have shown promise in other contexts.

Eligibility criteria

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.

Where this trial is running

New Haven, Connecticut and 6 other locations

• Yale Cancer Center — New Haven, Connecticut, United States (RECRUITING)
• University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (RECRUITING)
• Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
• NEXT- Oncology Dallas — Irving, Texas, United States (RECRUITING)
• NEXT Oncology- San Antonio — San Antonio, Texas, United States (RECRUITING)
• NEXT Oncology- Virginia — Fairfax, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Senior Medical Advisor

Conditions: Advanced Solid Tumor