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This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1826 | Drug | SHR-1826 for injection. |
| |
| SHR-1316 |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase II dose (RP2D) | Screening up to study completion, an average of 1 year. | |
| Adverse events (AEs) | Screening up to study completion, an average of 1 year. | |
| Objective response rate (ORR) | Screening up to study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Screening up to study completion, an average of 1 year. | |
| Duration of response (DoR) | Screening up to study completion, an average of 1 year. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijun Jia | Contact | +86-18801784695 | yijun.jia@hengrui.com | |
| Tingting Lei | Contact | +86-18610051325 | Tingting.lei.tl6@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Drug |
SHR-1316 for injection. |
|
| SHR-9839 | Drug | SHR-9839 for injection. |
|
| SHR-8068 | Drug | SHR-8068 for injection. |
|
| Ametinib mesylate | Drug | Ametinib mesylate. |
|
| BP-102 | Drug | BP-102 for injection. |
|
| Carboplatin | Drug | Carboplatin for injection. |
|
| Progression-free survival (PFS) |
| Screening up to study completion, an average of 1 year. |
| Overall survival (OS) | Screening up to study completion, an average of 1 year. |
| Drug resistant antibody (ADA) to SHR-1826 | Screening up to study completion, an average of 1 year. |
| Blood concentration of SHR-1826 | Screening up to study completion, an average of 1 year. |
| Blood concentration of free toxin | Screening up to study completion, an average of 1 year. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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