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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04446260

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

396

Starts

2020-09-07

Expected to finish

2025-06-04

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard 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 study screening until 6 months after receiving the last treatment

You may not qualify if…

• History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
• Known hereditary or acquired bleeding and thrombotic tendency

Where it is running

• 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

Full record on ClinicalTrials.gov

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