A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

Last updated: September 12, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

SHR-A1811

Clinical Study ID

NCT04446260
SHR-A1811-I-101
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Advanced/unresectable or metastatic solid tumor with HER2 expression or mutationthat is refractory to or intolerable with standard treatment, or for which nostandard treatment is available

  • 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 studyscreening until 6 months after receiving the last treatment

Exclusion

Exclusion Criteria:

  • History of clinically significant lung diseases (e.g., interstitial pneumonia,pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected tohave these diseases by imaging at screening period

  • Known hereditary or acquired bleeding and thrombotic tendency

Study Design

Total Participants: 396
Treatment Group(s): 1
Primary Treatment: SHR-A1811
Phase: 1
Study Start date:
September 07, 2020
Estimated Completion Date:
June 04, 2025

Connect with a study center

  • Macquarie University Hospital

    Macquarie, New South Wales 2155400 2109
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    Bedford Park 2076918, South Australia 2061327 5042
    Australia

    Site Not Available

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Nucleus Network

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston 2166144, Victoria 2145234 3199
    Australia

    Site Not Available

  • Nucleus Network

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, 3004
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne 2158177, 3004
    Australia

    Site Not Available

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui 233000
    China

    Site Not Available

  • The first affiliated hospital of bengbu medical college

    Bengbu 1816440, Anhui 1818058 233000
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349 100021
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fujian, Fuzhou 350000
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fujian 8422032, Fuzhou 350000
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Sun Yat-Sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou 1809858, Guangdong 1809935 510120
    China

    Site Not Available

  • Sun Yat-Sen Memorial Hospital, Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935 510120
    China

    Site Not Available

  • Henan cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Henan cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • Hubei cancer hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Zhongnan hospital of Wuhan university

    Wuhan, Hubei 430062
    China

    Site Not Available

  • Hubei cancer hospital

    Wuhan 1791247, Hubei 1806949 430079
    China

    Site Not Available

  • Zhongnan hospital of Wuhan university

    Wuhan 1791247, Hubei 1806949 430062
    China

    Site Not Available

  • Hunan cancer hospital

    Changsha, Hunan 410031
    China

    Site Not Available

  • Xiangya hospital central south university

    Changsha, Hunan 410008
    China

    Site Not Available

  • Hunan cancer hospital

    Changsha 1815577, Hunan 1806691 410031
    China

    Site Not Available

  • Xiangya hospital central south university

    Changsha 1815577, Hunan 1806691 410008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchuan, Jilin 130021
    China

    Site Not Available

  • Shengjing Hospital of China medical university

    Shengyang, Liaoning 2036115 110022
    China

    Site Not Available

  • Fudan University Shanghai cancer center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Fudan Unversity Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai Jiao Tong University School of Medicine Renji Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Fudan University Shanghai cancer center

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Fudan Unversity Zhongshan Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Shanghai Jiao Tong University School of Medicine Renji Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912 030000
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610042
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu 1815286, Sichuan 1794299 610042
    China

    Site Not Available

  • Tianjin medical university cancer institute&hoospital

    Tianjin, Tianjin 300181
    China

    Site Not Available

  • Tianjin medical university cancer institute&hoospital

    Tianjin 1792947, Tianjin Municipality 1792943 300181
    China

    Site Not Available

  • The second affiliated hospital Zhejiang university school of medicine

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Zhejiang provincial people's hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • The second affiliated hospital Zhejiang university school of medicine

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

  • Zhejiang provincial people's hospital

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, Gyeonggi-do 1841610 13620
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 5505
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 3080
    South Korea

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70457
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City 1668355, 70457
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Montefiore-Einstein Center for Cancer Care

    Bronx, New York 10461
    United States

    Site Not Available

  • Montefiore-Einstein Center for Cancer Care

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Gabrail Cancer Research Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Greenville Hospital System

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Prisma-Health Cancer Institute

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Greenville Hospital System

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Center for Oncology and Blood Disorders

    Houston, Texas 77030
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

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