New drug SHR-A1811 targets Hard-to-Treat cancers in early trial

NCT ID NCT04446260

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial tested a drug called SHR-A1811 in 396 people with advanced solid tumors that have HER2 expression or mutations and have stopped responding to standard treatments. The main goals were to check safety and how the drug moves through the body, while also looking for signs of tumor shrinkage. The drug is given by IV infusion, and the study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
SHR-A1811 (an antibody-drug conjugate given by IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have HER2 mutations or overexpression.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet proven to work. Side effects are possible, and the drug may not shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, 3004, Australia

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Fudan University Shanghai cancer center

    Shanghai, Shanghai Municipality, 200032, China

  • Fudan Unversity Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fujian, Fuzhou, 350000, China

  • Greenville Hospital System

    Greenville, South Carolina, 29605, United States

  • Henan cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hubei cancer hospital

    Wuhan, Hubei, 430079, China

  • Hunan cancer hospital

    Changsha, Hunan, 410031, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000, China

  • Macquarie University Hospital

    Macquarie, New South Wales, 2109, Australia

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Montefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461, United States

  • Nanfang Hospital

    Guangzhou, Guangdong, 510120, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • Nucleus Network

    Melbourne, Victoria, 3004, Australia

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199, Australia

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Shanghai Jiao Tong University School of Medicine Renji Hospital

    Shanghai, Shanghai Municipality, 200032, China

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000, China

  • Shengjing Hospital of China medical university

    Shengyang, Liaoning, 110022, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610042, China

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 5042, Australia

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

    Guangzhou, Guangdong, 510120, China

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233000, China

  • The second affiliated hospital Zhejiang university school of medicine

    Hangzhou, Zhejiang, 310014, China

  • Tianjin medical university cancer institute&hoospital

    Tianjin, Tianjin Municipality, 300181, China

  • Xiangya hospital central south university

    Changsha, Hunan, 410008, China

  • Zhejiang provincial people's hospital

    Hangzhou, Zhejiang, 310014, China

  • Zhongnan hospital of Wuhan university

    Wuhan, Hubei, 430062, China

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