A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer
NCT ID: NCT04839510
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
58 participants
INTERVENTIONAL
2021-04-20
2022-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRG002
MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).
MRG002
Administrated intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRG002
Administrated intravenously
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged 18 to 75 (including 18 and 75), both genders.
3. Expected survival time ≥ 12 weeks.
4. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.
5. Failed in the prior one or more line of systemic chemotherapy.
6. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test.
7. Archival or biopsy tumor specimens should be provided (primary or metastatic).
8. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
9. ECOG performance score 0 or 1.
10. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
11. No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
12. Organ function must meet the basic requirements.
13. Coagulation function must meet the basic requirements.
14. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.
Exclusion Criteria
2. Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment.
3. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
4. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.
5. Any severe or uncontrolled systemic diseases.
6. Patients with poorly controlled heart diseases.
7. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
8. History of other primary malignancies.
9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
10. Peripheral neuropathy greater than Grade 1.
11. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
12. Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
13. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
14. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
15. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Miracogen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aiping Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Municipality, China
Beijing hospital
Beijing, Beijing Municipality, China
Beijing Chao-Yang Hospital，Capital Medical University
Beijing, Beijing Municipality, China
The Fifth Medical Center of the PLA
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, 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 Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, 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 Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Changlu Hu
Role: primary
Dexin Yu
Role: primary
Aipingv Zhou, MD
Role: primary
Ben Wan
Role: primary
Yinong Niu
Role: primary
Lijun Chen
Role: primary
Hong Luo
Role: primary
Yu Chen
Role: primary
Fangjian Zhou
Role: primary
Yongda Liu
Role: primary
Hongyu Zhang
Role: primary
Pei Lu
Role: primary
Hui Chen
Role: primary
Shujun Yang
Role: primary
Guiling Li
Role: primary
Minfeng Chen
Role: primary
Weiqing Han
Role: primary
Ziling Liu
Role: primary
Jizhong Quan
Role: primary
Cheng Fu
Role: primary
Guojun Chen
Role: primary
Benkang Shi
Role: primary
Danfeng Xu
Role: primary
Chuanliang Xu
Role: primary
Lei Li
Role: primary
Yong Liao
Role: primary
Xin Yao
Role: primary
Hailong Hu
Role: primary
Jimin Chen
Role: primary
Shaoxing Zhu
Role: primary
Zhiliang Weng
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRG002-006
Identifier Type: -
Identifier Source: org_study_id