Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT04446260

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

396 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced malignant solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

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

Advanced solid tumors

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.