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This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6208 | Drug | HRS-6208. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | From Day 1 to 30 days after the last dose. | |
| Maximum tolerated dose (MTD) | From Day 1 to 21 days after the first dose. | |
| Dose limiting toxicity (DLT) | From Day 1 to 21 days after the first dose. | |
| Recommended phase 2 dose (RP2D) | From Day 1 to 30 days after the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). | |
| Duration of Response (DoR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Xu | Contact | 0518-82342973 | xin.xu@hengrui.com | |
| Zhiye Chen | Contact | 0518-82342973 | zhiye.chen.zc78@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Disease Control Rate (DCR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Progression free Survival (PFS) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Overall Survival (OS) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|