Clinical trial NCT04905914: Study Of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Aprea Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 132
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 3+3 Dose escalation design
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
timeFrame: Day 1 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Irving
country: United States
facility: NEXT- Oncology Dallas
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology- San Antonio
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology- Virginia
state: Virginia
Study officials:
affiliation: Aprea Therapeutics Inc
name: Crystal Miller, RN BSN
role: STUDY_DIRECTOR
References: