A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
NCT ID: NCT04446260
Last Updated: 2025-09-15
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
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COMPLETED
PHASE1
396 participants
INTERVENTIONAL
2020-09-07
2025-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1 Dose escalation
SHR-A1811
be administered via intravenous (IV) infusion
Part 2 PK expansion
SHR-A1811
be administered via intravenous (IV) infusion
Part 3 Indication expansion
SHR-A1811
be administered via intravenous (IV) infusion
Interventions
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SHR-A1811
be administered via intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* LVEF ≥ 50% by either ECHO or MUGA
* Has adequate renal and hepatic function
* Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment
Exclusion Criteria
* Known hereditary or acquired bleeding and thrombotic tendency
18 Years
ALL
No
Sponsors
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Atridia Pty Ltd.
INDUSTRY
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Montefiore-Einstein Center for Cancer Care
The Bronx, New York, United States
Greenville Hospital System
Greenville, South Carolina, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Macquarie University Hospital
Macquarie, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, , Australia
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fujian, Fuzhou, China
Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan cancer Hospital
Zhengzhou, Henan, China
Zhongnan hospital of Wuhan university
Wuhan, Hubei, China
Hubei cancer hospital
Wuhan, Hubei, China
Xiangya hospital central south university
Changsha, Hunan, China
Hunan cancer hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Shengjing Hospital of China medical university
Shengyang, Liaoning, China
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, China
Fudan Unversity Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Jiao Tong University School of Medicine Renji Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin medical university cancer institute&hoospital
Tianjin, Tianjin Municipality, China
The second affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, China
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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References
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Yao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20.
Other Identifiers
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SHR-A1811-I-101
Identifier Type: -
Identifier Source: org_study_id
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