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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg ATRN-119 | Experimental | Once daily oral administration. |
|
| 100mg ATRN-119 | Experimental | Once daily oral administration. |
|
| 200mg ATRN-119 | Experimental | Once daily oral administration. |
|
| 350mg ATRN-119 | Experimental | Once daily oral administration. |
|
| 400mg ATRN-119 | Experimental | Twice daily oral administration. |
|
| 1100mg ATRN-119 | Experimental | Once daily oral administration |
|
| 1300mg ATRN-119 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crystal Miller, RN BSN | Aprea Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States | ||
| University Hospitals, Cleveland Medical Center |
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3+3 Dose escalation design
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| Experimental |
Once daily oral administration |
|
| 1500mg ATRN-119 | Experimental | Once daily oral administration |
|
| 650mg ATRN-119 | Experimental | Twice daily oral administration. |
|
| 750mg ATRN-119 | Experimental | Twice daily oral administration. |
|
| 550mg ATRN-119 | Experimental | Once or twice daily oral administration |
|
| 800 mg ATRN-119 | Experimental | Once daily oral administration |
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| NEXT- Oncology Dallas | Irving | Texas | 75039 | United States |
| NEXT Oncology- San Antonio | San Antonio | Texas | 78229 | United States |
| NEXT Oncology- Virginia | Fairfax | Virginia | 22031 | United States |