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The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI325 and sintilimab combination does-escalation | Experimental |
| |
| IBI325 monotherapy does-escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI325 + sintilimab | Drug | IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with DLT | Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose | 28 days post first dose |
| Number of patients with treatment related AEs | Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose | Up to 90 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with response | Number of patients with response per RECIST 1.1 | Every 6 weeks until progressive disease or up to 24 months after treatment |
| The area under the curve (AUC) | Up to 90 days post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Province Cancer Hospital | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| IBI325 | Drug | IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation |
|
| Maximum concentration (Cmax) | Up to 90 days post last dose |
| Time at which maximum concentration (Tmax) | Up to 90 days post last dose |
| The half-life (t1/2) | Up to 90 days post last dose |
| Positive rate of ADA and Nab | Up to 90 days post last dose |