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The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Intervention: Drug: SHR-A1811 combined with Pyrotinib | Experimental |
| |
| Part B1: Intervention: Drug: SHR-A1811 combined with other antitumor therapies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 combined with Pyrotinib. | Drug | SHR-A1811 combined with Pyrotinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximally Tolerated Dose (MTD),)(Phase ⅠB). | From the first dose to the last dose, about 11 months | |
| Part A: recommended phase 2 dose (RP2D)(Phase ⅠB). | From the first dose to the last dose, about 11 months | |
| Part A: Adverse Events (Phase ⅠB) | From the first dose to the last dose, about 11 months | |
| Part A: Objective Response Rate (ORR) (Phase Ⅱ) | From the first dose to the last dose, about 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: ORR (Phase ⅠB). | From the first dose to the last dose, about 11 months. | |
| Part A: Disease Control Rate (DCR) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 11 months | |
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Inclusion Criteria:
Exclusion Criteria:
For Part B1, subjects must not meet any of the following supplementary criteria at the same time, otherwise they will not be enrolled in the study:
1、Presence of grade >1 peripheral neuropathy.
For those who plan to receive BP102 combination therapy, subjects must not meet any of the following supplementary criteria at the same time, otherwise they will not be enrolled in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengjin Zhang | Contact | +0518-82342973 | zhengjin.zhang.zz79@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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| SHR-A1811 combined with other antitumor therapies | Drug | SHR-A1811 combined with other antitumor therapies |
|
| Part A: Duration of Response (DoR) (Phase ⅠB and Phase Ⅱ) |
| From the first dose to the last dose, about 11 months |
| Part A: Progression-free survival (PFS) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 13 months. |
| Part A: Overall survival (OS) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 13 months |
| Part A: Adverse Events (PhaseⅡ). | about 11 months. |
| Peking University Cancer Hospital & Institute-Department of Gastrointestinal Oncology | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Recruiting | Nanning | Guangxi | 530021 | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Harbin Medical University Cancer Hospital-The Eighth Department of Internal Medicine | Recruiting | Harbin | Heilongjiang | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Hubei Cancer Hospital-Department of Abdominal Oncology | Recruiting | Wuhan | Hubei | 430079 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330200 | China |
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| Shanxi Provincial Cancer Hospital-Gastroenterology Department | Recruiting | Taiyuan | Shanxi | 030013 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Tianjin Medical University Cancer Institute and Hospital-Department of digestive oncology | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
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