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This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1681 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1681 | Drug | SHR-1681 for Injection will be administrated per dose level in which the patients are assigned. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | 12 months. | |
| Maximum administered dose (MAD) | 12 months. | |
| Recommended Phase 2 dose (RP2D) | 12 months. | |
| Incidence and severity of adverse events (AEs) | Approximately 3 years. | |
| Incidence and severity of serious adverse events (SAEs) | Approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) of SHR-1681 | Approximately 3 years. | |
| Maximum concentration (Cmax) of SHR-1681 | Approximately 3 years. | |
| Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Qiu | Contact | +86-0518-82342973 | fei.qiu@hengrui.com | |
| Ting Lu, M.M | Contact | +86-18825721498 | ting.lu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dongfang Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Approximately 3 years. |
| Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681 | Approximately 3 years. |
| Anti-SHR-1681 antibody (ADA) of SHR-1681 | Approximately 3 years. |
| Overall response rate (ORR) | Approximately 3 years. |
| Duration of response (DoR) | Approximately 3 years. |
| Disease control rate (DCR) | Approximately 3 years. |
| Progression-free survival (PFS) | Approximately 3 years. |
| Overall survival (OS) | Approximately up to 5 years after the last subject enrolled. |