Study Of ATRN-119 In Patients With Advanced Solid Tumors

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: ATRN-119


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 3+3 Dose escalation design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|
| Experimental: 100mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|
| Experimental: 200mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|
| Experimental: 350mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|
| Experimental: 550mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|
| Experimental: 800mg ATRN-119<br>Once daily oral administration. | Drug: ATRN-119<br>* ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 56 |