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The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATB-320 | Experimental | Participants will receive ATB-320 in cycles. One cycle will consist of 4 weeks (28 days). The study will start with Cohort 1 and the progression to the next cohort will depend on the occurrence of dose limiting toxicity (DLT). The dosage regimen of the investigational product is as follows: Cohort 1: 1.0 mg/kg Cohort 2: 2.0 mg/kg Cohort 3: 4.0 mg/kg Cohort 4: 8.0 mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATB-320 | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Occurrence of dose limiting toxicity (DLT) will be assessed for the DLT Analysis Set for each cohort until Cycle 1 Day 28 (C1D28) and will be discussed by the Data Monitoring Committee (DMC). | First dose to Cycle 1 Day 28 (each cycle is 28 days) |
| Maximum Tolerated Dose (MTD) | The highest dose (cohort) at which no more than one out of three to six participants in a cohort experience a dose limiting toxicity (DLT). | At the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of participants with AE, with abnormal physical examination findings, abnormal vital signs, abnormal ECG readings, abnormal clinical laboratory tests results | At the end of each cycle (each cycle is 28 days) and up to 14 days from the last dose of ATB-320 |
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Inclusion Criteria:
Exclusion Criteria:
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3+3 design
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