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This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.
This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corhort A | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic NSCLC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Corhort B | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic BC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Corhort C | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic HNSCC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Corhort D | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Other locally advanced cancer patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL202 should be intravenously infused | Drug | For each patient, YL202 should be intravenously infused over 60±10 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed according to RECIST v1.1 | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | By the end of trial date, approximately within 36 months |
| Determination of the recommended dose of YL202 in the pivotal clinical study | By the end of trial date, approximately within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed according to RECIST v1.1 | approximately within 36 months | |
| Clinical benefit rate (CBR) assessed according to RECIST v1.1 | approximately within 36 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Tumour Hospital | Recruiting | Hefei | Anhui | China |
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| depth of response (DpR) assessed according to RECIST v1.1 |
| Approximately within 36 months |
| disease control rate (DCR) assessed according to RECIST v1.1 | Approximately within 36 months |
| duration of response (DOR) assessed according to RECIST v1.1 | Approximately within 36 months |
| time to response (TTR) assessed according to RECIST v1.1 | Approximately within 36 months |
| Evaluate the overall survival (OS) | Approximately within 36 months |
| Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment | Approximately within 36 months |
| Characterize the PK parameter AUC | steady-state area under curve (AUC) | Approximately within 36 months |
| Characterize the PK parameter Cmax | peak concentration (Cmax) | Approximately within 36 months |
| Characterize the PK parameter Ctrough | trough concentration (Ctrough) | Approximately within 36 months |
| Characterize the PK parameter CL | clearance (CL) | Approximately within 36 months |
| Characterize the PK parameter Vd | volume of distribution (Vd) | Approximately within 36 months |
| Characterize the PK parameter t1/2 | half-life (t1/2) | Approximately within 36 months |
| Incidence of anti-YL202 antibody | approximately within 36 months |
| Establish a POP PK model for exposure-response relationship analysis | approximately within 36 months |
| Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate | approximately within 36 months |
| The first affiliated hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| The Second Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
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| Beijing Cancer hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Beijing Tsinghua Chang Gung Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Chongqing University Affiliated Tumor Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| The first affiliated hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Xinqiao Hospital of AMU | Recruiting | Chongqing | Chongqing Municipality | China |
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| Xinqiao Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| Fujian Tumor Hospital | Recruiting | Fuzhou | Fujian | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| The Sixth Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
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| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Meizhou People's Hospital | Recruiting | Meizhou | Guangdong | China |
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| Shantou University Medical College Tumour Hospital | Recruiting | Shantou | Guangdong | China |
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| Guilin Medical College Second Affiliated Hospital | Recruiting | Guilin | Guangxi | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | 530021 | China |
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| Guangxi Medical University Affiliated Tumour Hospital | Recruiting | Nanning | Guangxi | China |
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| The People's Hospital of Guangxi | Recruiting | Nanning | Guangxi | China |
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| Harbin Medical university cancer hospital | Recruiting | Harbin | Heilongjiang | China |
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| The First Affiliated Hospital Of Henan University&Technology | Not yet recruiting | Luoyang | Henan | China |
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| The First Affiliated Hospital of Nanyang Medical College | Recruiting | Nanyang | Henan | China |
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| Xinxiang Medical University No.1 Affiliated Hospital | Recruiting | Xinxiang | Henan | China |
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| He'nan Cancer Hospital South Gate | Recruiting | Zhengzhou | Henan | China |
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| Henan Provincial Chest Hospital | Recruiting | Zhengzhou | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| The First Peoples Hospital of Jingzhou | Recruiting | Jingzhou | Hubei | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | China |
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| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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| Union Hospital Tongji Medical College HuaZhong University of Science Technology | Not yet recruiting | Wuhan | Hubei | China |
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| Union Hospital, Tongji Medical College,Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | China |
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| Hu'nan Province Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | China |
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| Xiangya hospital Central South University | Recruiting | Changsha | Hunan | China |
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| The Third People's Hospital of Hunan Province | Recruiting | Yueyang | Hunan | China |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
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| First Affiliated Hospital of Gannan Medical University | Not yet recruiting | Ganzhou | Jiangxi | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| The Affiliated Hospital of NanChang University | Not yet recruiting | Nanchang | Jiangxi | China |
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| The Third Hospital of Nanchang | Recruiting | Nanchang | Jiangxi | China |
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| Jilin Provincial Cancer Hospital | Recruiting | Changchun | Jilin | 215000 | China |
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| China-Japan Union Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| The second Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| Fukuang General Hospital of Liaoning Health Industry Group | Not yet recruiting | Fushun | Liaoning | 530021 | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | China |
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| The First Hospital of China Medical University Physical Examination Center | Not yet recruiting | Shenyang | Liaoning | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Jinan Central Hospital Affiliated to Shandong University | Recruiting | Jinan | Shandong | China |
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| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | China |
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| Shandong Provincial Public Health Clinical Center | Not yet recruiting | Jinan | Shandong | China |
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| Affiliated Hospital of Jining Medical University | Not yet recruiting | Jining | Shandong | China |
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| Linyi Cancer hospital | Recruiting | Linyi | Shandong | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
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| Weifang People's Hospital | Not yet recruiting | Weifang | Shandong | China |
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| Huashan Hospital affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Ninth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| The Affiliated Huashan Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| The No.10 Peoples Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Province Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
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| The First Affiliated Hospital Of Xi'an JiaoTong University | Not yet recruiting | Xian | Shanxi | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | China |
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| SiChuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| West China Hospital,Sichuan Universtiy | Not yet recruiting | Chengdu | Sichuan | China |
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| The Affiliated Cancer Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| Yunnan Tumor Hospital | Recruiting | Kunming | Yunnan | China |
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| The Second Affiliated Hospital of Zhejiang University school of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| ZheJiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Province People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Province People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang University Medical College Affiliated No.1 Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Yiwu Central Hospital | Recruiting | Jinhua | Zhejiang | China |
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| Taizhou Hospital of Zhejiang | Recruiting | Taizhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
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