Study Of ATRN-119 In Patients With Advanced Solid Tumors

NCT04905914 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AR-276-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 7

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 28

Study Arms (12)

50mg ATRN-119

EXPERIMENTAL

Once daily oral administration.

Drug: ATRN-119

100mg ATRN-119

EXPERIMENTAL

Once daily oral administration.

Drug: ATRN-119

200mg ATRN-119

EXPERIMENTAL

Once daily oral administration.

Drug: ATRN-119

350mg ATRN-119

EXPERIMENTAL

Once daily oral administration.

Drug: ATRN-119

400mg ATRN-119

EXPERIMENTAL

Twice daily oral administration.

Drug: ATRN-119

1100mg ATRN-119

EXPERIMENTAL

Once daily oral administration

Drug: ATRN-119

1300mg ATRN-119

EXPERIMENTAL

Once daily oral administration

Drug: ATRN-119

1500mg ATRN-119

EXPERIMENTAL

Once daily oral administration

Drug: ATRN-119

650mg ATRN-119

EXPERIMENTAL

Twice daily oral administration.

Drug: ATRN-119

750mg ATRN-119

EXPERIMENTAL

Twice daily oral administration.

Drug: ATRN-119

550mg ATRN-119

EXPERIMENTAL

Once or twice daily oral administration

Drug: ATRN-119

800 mg ATRN-119

EXPERIMENTAL

Once daily oral administration

Drug: ATRN-119

Interventions

ATRN-119 DRUG

ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.

100mg ATRN-119; 1100mg ATRN-119; 1300mg ATRN-119; 1500mg ATRN-119; 200mg ATRN-119; 350mg ATRN-119; 400mg ATRN-119; 50mg ATRN-119; 550mg ATRN-119; 650mg ATRN-119; 750mg ATRN-119; 800 mg ATRN-119

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aprea Therapeutics: lead

Study Sites (7)

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

NEXT- Oncology Dallas

Irving, Texas, 75039, United States

Location

NEXT Oncology- San Antonio

San Antonio, Texas, 78229, United States

Location

NEXT Oncology- Virginia

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Crystal Miller, RN BSN

  Aprea Therapeutics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Dose escalation design

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 28, 2021
• Study Start: January 9, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)