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This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.
The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS207 in combination with 9MW2821 | Drug | JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(ORR) evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria | 2years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of response (DoR) evaluated based on RECIST v1.1 | 2years |
| DCR | Disease control rate (DCR) evaluated based on RECIST v1.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Nectin-4 expression | The correlation between Nectin-4 expression in tumor tissue and therapeutic efficacy | 2years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaoqiang Yang, Master | Contact | 18252095266 | chaoqiang_yang@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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None(open label)
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| JS207 in combination with Albumin paclitaxel | Drug | JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W). |
|
| 2years |
| PFS | Progression-free survival (PFS) evaluated based on RECIST v1.1 | 2years |
| OS | The time from first dose to death from any cause | 3years |
| AE | Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v5.0 | 2years |
| Plasma concentrations | Plasma concentrations of JS207 and 9MW2821. | 2years |
| ADA | The incidence and titer of anti-drug antibodies (ADA) of JS207 and 9MW2821 | 2years |
| Nab | The incidence of Nab(if applicable) of JS207 and 9MW2821 | 2years |
| PD-L1 | The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy | 2years |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| Guangdong women and children's hospital and health institute | Not yet recruiting | Guangzhou | Guangdong | 511400 | China |
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| Affiliated Hospital of Hebei University | Recruiting | Baoding | Hebei | 071030 | China |
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| Harbin Medical University Affiliated Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| Harbin Medical University Affiliated Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| Henan Cancer Hospital | Recruiting | Zhangzhou | Henan | 450003 | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Nanchang People'S Hospital | Not yet recruiting | Nanchang | Jiangxi | 330000 | China |
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| Jilin University First Hospital | Recruiting | Changchun | Jilin | 130021 | China |
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| The Second Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116027 | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110002 | China |
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| Liaoning Cancer Hospital&Institute | Recruiting | Shenyang | Liaoning | 110801 | China |
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| Ceneral Hosipital of Ningxia Medical University | Not yet recruiting | Yinchuan | Ningxia | 750000 | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266035 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xian | Shanxi | 710061 | China |
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| Xi'an International Medical Center Hospital | Recruiting | Xian | Shanxi | 710100 | China |
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| Affiliated Tumor Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830000 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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