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 GQ1005 takes on T-DM1 in advanced HER2-Positive breast cancer

NCT ID NCT07673029

Disease control Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a new drug called GQ1005 works better than the current standard treatment T-DM1 for people with HER2-positive breast cancer that has spread or cannot be removed by surgery. Participants have already been treated with trastuzumab and a taxane. The study measures how long the cancer stays under control and overall survival.

What this could mean

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

Active substance
GQ1005
What this could lead to
If GQ1005 works better than T-DM1, it could offer a new treatment option for people with HER2-positive breast cancer that has spread or cannot be removed by surgery.
What could go wrong
This is a phase 3 trial, but results may not show a clear benefit over the existing drug T-DM1. Side effects of GQ1005 are still being studied and could be similar or different from T-DM1.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

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 to 75 years

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: * Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1. * Presence of at least one measurable lesion according to RECIST v1.1 * Expected survival time ≥ 12 weeks. * Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. Exclusion Criteria: * Prior anti-HER2 ADC therapy. * Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy. * Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs. * Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer * Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult * Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HER2-positive breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    70 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Cancer Hospital

    RECRUITING

    Hefei, Anhui, 230031, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Deyang People's Hospital

    RECRUITING

    Deyang, Sichuan, 618000, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Ganzhou Cancer Hospital

    RECRUITING

    Ganzhou, Jiangxi, 341000, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Guizhou Medical University Cancer Hospital

    RECRUITING

    Guiyang, Guizhou, 550004, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276001, China

  • Linyi Central Hospital

    RECRUITING

    Linyi, Shandong, 276003, China

  • Luoyang Central Hospital

    RECRUITING

    Luoyang, Henan, 471000, China

  • Meizhou People's Hospital

    RECRUITING

    Meizhou, Guangdong, 514011, China

  • Nanchang People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai Gaobo Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201103, China

  • Shantou Central Hospital

    RECRUITING

    Shantou, Guangdong, 515031, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 30013, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Suining Central Hospital

    RECRUITING

    Suining, Sichuan, 629000, China

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

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Fuyang Hospital of Anhui Medical University

    RECRUITING

    Fuyang, Anhui, 236000, China

  • The Affiliated Hospital of Hebei University

    RECRUITING

    Baoding, Hebei, 71000, China

  • The Affiliated Hospital of Hebei University of Engineering

    RECRUITING

    Handan, Hebei, 56002, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266003, China

  • The Affiliated People's Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315040, China

  • The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Affiliated Hospital of Henan Medical University

    RECRUITING

    Xinxiang, Henan, 453003, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Jinzhou Medical University

    RECRUITING

    Jinzhou, Liaoning, 121001, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The First People's Hospital of Hangzhou City

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • The First People's Hospital of Xiaoshan District, Hangzhou City

    RECRUITING

    Hangzhou, Zhejiang, 311200, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 50011, China

  • The Second Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116023, China

  • The Second Affiliated Hospital of Fujian Medical University

    RECRUITING

    Quanzhou, Fujian, 362000, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second People's Hospital of Liaocheng City

    RECRUITING

    Linqing, Shandong, 252601, China

  • The Second People's Hospital of Neijiang City

    RECRUITING

    Neijiang, Sichuan, 641003, China

  • The Third People's Hospital of Chengdu City

    RECRUITING

    Chengdu, Sichuan, 610031, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Weifang People's Hospital

    RECRUITING

    Weifang, Shandong, 261041, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Women's Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Xingtai People's Hospital

    RECRUITING

    Xingtai, Hebei, 54001, China

  • Xuchang Central Hospital

    RECRUITING

    Xuchang, Henan, 461000, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221009, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

  • Yidu Central Hospital of Weifang City

    RECRUITING

    Qingzhou, Shandong, 262500, China

  • Yongzhou Central Hospital

    RECRUITING

    Yongzhou, Hunan, 425000, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430071, China

More trials for these conditions

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