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This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2009 | Drug | In dose Escalation: SHR-A2009 will be administered intravenously. Six dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) or maximum administered dose (MAD). | Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment. | From Day 1 to Day 21 |
| Recommended Phase 2 dose (RP2D) | RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages. | From Day 1 to 90 days after last dose |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). | From Day 1 to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of SHR-A2009 | Time to maximum concentration of SHR-A2009 | approximately 6 months |
| Cmax of SHR-A2009 | Maximum concentration of SHR-A2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Shi, MD, PhD | Contact | +86 021-61053363 | wei.shi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Recruiting | Chongqicun | Chongqi | 400000 | China |
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Single arm study of SHR-A2009
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| approximately 6 months |
| AUC0-t of SHR-A2009 | area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009 | approximately 6 months |
| AUC0-∞ of SHR-A2009 | area under the concentration-time curve from time 0 to infinity of SHR-A2009 | approximately 6 months |
| Immunogenicity of SHR-A2009 | Anti-SHR-A2009 antibody (ADA) | approximately 9 months |
| Overall response rate (ORR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Duration of response (DoR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Disease control rate (DCR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Progression-free survival (PFS) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| The First Hospital of JiLin University | Recruiting | Changchun | Jlin | 132000 | China |
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| Shandong Cancer Hospital&Institute | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| The Second Affiliated Hospital of Air Force Military University Tangdu Hospital | Not yet recruiting | Xi’an | Shanxi | 710000 | China |
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| Sichuan Cancer Hospital & Institute | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| West China Hospital,Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650000 | China |
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| National Cancer Center Hospital East | Not yet recruiting | Chiba | 277-8577 | Japan |
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| National Cancer Center Hospital | Not yet recruiting | Tokyo | 104-0045 | Japan |
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| Seoul National University Hospital | Not yet recruiting | Seoul | 03080 | South Korea |
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| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center | Not yet recruiting | Seoul | 06351 | South Korea |
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