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The sponsor's R&D strategy is adjusted.
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To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the recommended dose for Phase II clinical studies (RP2D)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7053 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7053 Injection | Drug | HRS-7053 is administered by intravenous (IV) infusion once a week (QW) for one treatment cycle every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AES) | up to 3 years | |
| MTD | up to 3 years | |
| RP2D | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | up to 3 years | |
| Maximum concentration (Cmax) | up to 3 years | |
| Area under the time curve from 0 to the last measurable concentration time point t (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| up to 3 years |
| Objective response rate (ORR) | up to 3 years] |
| Disease control rate (DCR) | up to 3 years |
| Progression-free survival (PFS) | up to 3 years |
| Duration of response (DoR) | up to 3 years |
| Overall survival (OS) | up to 3 years |