Study Of ATRN-119 In Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrin Pharmaceuticals

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:

• 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.