New hope for Hard-to-Treat breast cancer: JSKN003 enters final trial phase

NCT ID NCT06079983

Disease control Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new drug called JSKN003 against standard chemotherapy in 400 people with HER2-low breast cancer that has spread and stopped responding to earlier treatments. Participants are randomly assigned to receive either JSKN003 or a standard chemo drug chosen by their doctor. The goal is to see if JSKN003 can delay cancer growth better than current options.

What this could mean

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

Active substance: JSKN003 (a drug given intravenously)
What this could lead to: If it works, this could provide a new treatment option for people with HER2-low breast cancer that has spread and stopped responding to earlier therapies.
What could go wrong: This is a Phase 3 trial, but the drug is still experimental. It may not improve survival or could have side effects. Results may not apply to all patients.

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 400 people

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

Started

Dec 2023

Expected to finish

Mar 2029

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 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: * 1\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form. 2\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female. 3\. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+. 4\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage. 5\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status. 6\. Documented radiographic disease progression (during or after the most recent treatment). 7\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 8\. Expected survival ≥ 3 months. 9. ECOG score of 0 or 1 within 14 days prior to administration. 10. Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent. 11\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria. 12\. Have sufficient elution of previous treatment before administration. Exclusion Criteria: * 1\. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis. 2\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration. 4\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed. 5\. Previous use of antibody conjugates containing topoisomerase I inhibitors. 6. There is a third gap fluid that cannot be controlled by drainage, etc. 7. Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy. 8\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug. 9\. Previous or current autoimmune disease. 10. Have uncontrolled comorbidities. 11. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0). 12\. History of previous immunodeficiency. 13. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation. 14\. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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

The places running it

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

Affiliated Hospital of Chengde Medical University
RECRUITING

Chengde, China
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING

Baoding, China
Affiliated Hospital of Inner Mongolia Medical University
RECRUITING

Hohhot, China
Affiliated Hospital of Jining Medical University
RECRUITING

Jining, China
Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING

Qingdao, China
Affiliated Hospital of Qinghai University
RECRUITING

Xining, China
Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING

Xuzhou, China
Affiliated Tumor Hospital of Xinjiang Medical University
RECRUITING

Ürümqi, China
Anhui Provincial Hospital
NOT_YET_RECRUITING

Hefei, China
Anyang Cancer Hospital
NOT_YET_RECRUITING

Anyang, China
Beijing Luhe Hospital
NOT_YET_RECRUITING

Beijing, China
Bethune First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, China
Cancer Hospital Affiliated to Guangxi Medical University
NOT_YET_RECRUITING

Nanning, China
Cancer Hospital Affiliated to Shantou University School of Medicine
NOT_YET_RECRUITING

Shantou, China
Cancer Hospital of Chongqing University
NOT_YET_RECRUITING

Chongqing, China
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING

Beijing, China
Central South University Xiangya Hospital
NOT_YET_RECRUITING

Changsha, China
Erwei Song
NOT_YET_RECRUITING

Guangzhou, Guangdong, China
Fudan University Cancer Hospital
NOT_YET_RECRUITING

Shanghai, China
Fujian Cancer Hospital
NOT_YET_RECRUITING

Fuzhou, China
Fujian Provincial Hospital
RECRUITING

Fuzhou, China
Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING

Lanzhou, China
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING

Guangzhou, China
Guangxi Zhuang Autonomous Region People's Hospital
NOT_YET_RECRUITING

Nanning, China
Guizhou Provincial People's Hospital
RECRUITING

Guiyang, China
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Ha’erbin, China
Henan Provincial Cancer Hospital
RECRUITING

Zhengzhou, China
Hubei Provincial Cancer Hospital
RECRUITING

Wuhan, China
Hunan Cancer Hospital
RECRUITING

Changsha, China
Jiangmen Central Hospital
RECRUITING

Jiangmen, China
Jiangsu Provincial Cancer Hospital
RECRUITING

Nanjing, China
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING

Nanjing, China
Jiangxi Provincial Cancer Hospital
RECRUITING

Nanchang, China
Jilin Provincial Cancer Hospital
NOT_YET_RECRUITING

Changchun, China
Jiong Wu
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, China
Liaoning Cancer Hospital
RECRUITING

Shengyang, China
Linyi Cancer Hospital
NOT_YET_RECRUITING

Linyi, China
Linyi People's Hospital
NOT_YET_RECRUITING

Linyi, China
Meizhou People's Hospital
RECRUITING

Meizhou, China
Peking University Cancer Hospital
RECRUITING

Beijing, China
People's Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, China
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, China
Shandong Cancer Hospital
RECRUITING

Jinan, China
Shanxi Bethune Hospital
NOT_YET_RECRUITING

Taiyuan, China
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING

Taiyuan, China
Sichuan Cancer Hospital
RECRUITING

Chengdu, China
Sichuan Provincial People's Hospital
RECRUITING

Chengdu, China
Suining Central Hospital
RECRUITING

Suining, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, China
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING

Guanzhou, China
The Affiliated Hospital of Guangdong Medical University
RECRUITING

Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
RECRUITING

Guiyang, China
The Affiliated Hospital of Zunyi Medical University
RECRUITING

Zunyi, China
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, China
The First Affiliated Hospital of China Medical University
RECRUITING

Beijing, China
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING

Chongqing, China
The First Affiliated Hospital of Gannan Medical University
RECRUITING

Ganzhou, China
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING

Luoyang, China
The First Affiliated Hospital of University of South China
RECRUITING

Hengyang, China
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING

Xi'an, China
The First Affiliated Hospital of Xiamen University
RECRUITING

Xiamen, China
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING

Xinxiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hanzhou, China
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, China
The First Hospital of Lanzhou University
RECRUITING

Lanzhou, China
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
NOT_YET_RECRUITING

Beijing, China
The First People's Hospital of Changde
RECRUITING

Changde, China
The First People's Hospital of Zhaoqing
RECRUITING

Zhaoqing, China
The People's Hospital of Northern Guangdong
RECRUITING

Shaoguan, China
The Second Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, China
The Second Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING

Dalian, China
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING

Suzhou, China
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING

Xi'an, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hanzhou, China
The Second People's Hospital of Neijiang
RECRUITING

Neijiang, China
The Third Hospital of Nanchang
RECRUITING

Nanchang, China
Tianjin Cancer Hospital
RECRUITING

Tianjin, China
Union Hospital Affiliated to Fujian Medical University
RECRUITING

Fuzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, China
West China Hospital, Sichuan University
NOT_YET_RECRUITING

Chengdu, China
Xiangyang Central Hospital
NOT_YET_RECRUITING

Xiangyang, China
Xuzhou Central Hospital
RECRUITING

Xuzhou, China
Yongzhou Central Hospital in Hunan Province
RECRUITING

Yongzhou, China
Yunnan Cancer Hospital
NOT_YET_RECRUITING

Kunming, China
Zhejiang Cancer Hospital
NOT_YET_RECRUITING

Hanzhou, China
Zhejiang Taizhou Hospital
RECRUITING

Taizhou, China
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, China

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