Spots Global Cancer Trial Database for A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer
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Trial Identification
Brief Title: A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer
Official Title: An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer
Study ID: NCT04839510
Interventions
Study Description
Brief Summary: The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive unresectable locally advanced or metastatic urothelium cancer.
Detailed Description: The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of second stage Phase IIb single-arm study either will be continued or the trail will be terminated. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 33 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui provincial Cancer Hospital, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Beijing hospital, Beijing, Beijing, China
Beijing Chao-Yang Hospital，Capital Medical University, Beijing, Beijing, China
The Fifth Medical Center of the PLA, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
Army Medical Center of PLA, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
SUN Yat-sen university Cancer center, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
ShenZhen Luohu People's Hospital, ShenZhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
Liuzhou People's Hospital, Liuzhou, Guangxi, China
Haerbin medical university cancer hospital, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Union hospital tongji medical college huazhong univerity ofscience and technology, Wuhan, Hubei, China
Tongji Hospital, Wuhan, Hubei, China
Xiangya hospital central south university, Changsha, Hunan, China
The Affiliated Cancer Hospital of Xiangya School of Medicine(Hunan Cancer Hospital ), Changsha, Hunan, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
JiLinGuoWen Hospital, Siping, Jilin, China
Liaoning Cancer hospital, Shenyang, Liaoning, China
Qinghai University Affiliated Hospital, Xining, Qinghai, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Rui jin hospital, Shanghai, Shanghai, China
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Changhai Hospital, Shanghai, Shanghai, China
First Affiliated Hospital of Xi'an Jiaotong University, Xian, Shanxi, China
Sichuan provincial people's hospital, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, China
The second Affiliated Hospital Zhejiang University School of Medical, Hangzhou, Zhejiang, China
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, China
The 1'Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Contact Details
Name: Aiping Zhou, MD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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