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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 combined with Sintilimab in patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI325 and Sintilimab combination does-escalation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI325+Sintilimab | Drug | IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination 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 42 days after the first dose | 42 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, whichever came first |
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Inclusion
1. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
3. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuping Sun | Contact | 0531-67626073 | ywb234@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Province Cancer Hospital | Jinan | Shandong | 250117 | China |
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