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| Name | Class |
|---|---|
| Shanghai Xianxiang Medical Technology Co., Ltd. | INDUSTRY |
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This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIM0508 mono dose escalation | Experimental | Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose. |
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| SIM0508 combination dose escalation | Experimental | Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose. |
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| SIM0508 in combination with olaparib | Experimental | Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0508 Tablets | Drug | Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Primary Endpoints | At the end of Cycle 1 (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Wen Wang | Contact | 65212241 | 010 | wangwenjuan4@zaiming.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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| SIM0508 in combination with olaparib | Drug | Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose. |
|
| SIM0508 in combination with olaparib | Drug | Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation. |
|
| Chongqing Cancer Hospital | Recruiting | Chongqing | China |
|