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Clinical Trials in China / NCT06079983
Recruiting Phase 3

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

NCT06079983 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Phase
Phase 3
Started
2023-12-01
Last updated
2025-09-12

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

JSKN003Capecitabine tabletsGemcitabine hydrochloride for injectionVinorelbine tartrate injectionPaclitaxel for injection (albumin-bound type)Docetaxel injectionEribulin mesylate injection

JSKN003: Administered intravenously according to protocol.

Capecitabine tablets: Administered according to protocol, as one option for investigator's choice (determined before randomization).

Gemcitabine hydrochloride for injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).

Vinorelbine tartrate injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).

Paclitaxel for injection (albumin-bound type): Administered according to protocol, as one option for investigator's choice (determined before randomization).

Docetaxel injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).

Eribulin mesylate injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).

Study summary

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.

The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:

* Experimental group: JSKN003 monotherapy
* Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
Erwei Song Guangzhou Guangdong Not Yet Recruiting
Jiong Wu Shanghai Shanghai Municipality Not Yet Recruiting
Anyang Cancer Hospital Anyang China Not Yet Recruiting
Affiliated Hospital of Hebei University Baoding China Not Yet Recruiting
Beijing Luhe Hospital Beijing China Not Yet Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting
Peking University Cancer Hospital Beijing China Recruiting
The First Affiliated Hospital of China Medical University Beijing China Recruiting
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army Beijing China Not Yet Recruiting
Bethune First Hospital of Jilin University Changchun China Not Yet Recruiting
Jilin Provincial Cancer Hospital Changchun China Not Yet Recruiting
The First People's Hospital of Changde Changde China Recruiting
Central South University Xiangya Hospital Changsha China Not Yet Recruiting
Hunan Cancer Hospital Changsha China Recruiting
Affiliated Hospital of Chengde Medical University Chengde China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
West China Hospital, Sichuan University Chengdu China Not Yet Recruiting
Cancer Hospital of Chongqing University Chongqing China Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing China Not Yet Recruiting
The Second Affiliated Hospital of Dalian Medical University Dalian China Not Yet Recruiting
Fujian Cancer Hospital Fuzhou China Not Yet Recruiting
Fujian Provincial Hospital Fuzhou China Recruiting
Union Hospital Affiliated to Fujian Medical University Fuzhou China Recruiting
The First Affiliated Hospital of Gannan Medical University Ganzhou China Recruiting
Guangdong Provincial People's Hospital Guangzhou China Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou China Not Yet Recruiting
The Affiliated Hospital of Guangdong Medical University Guangzhou China Recruiting
Sun Yat-sen University Cancer Center Guanzhou China Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang China Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang China Recruiting
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine Hangzhou China Not Yet Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine Hanzhou China Not Yet Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine Hanzhou China Not Yet Recruiting
Zhejiang Cancer Hospital Hanzhou China Not Yet Recruiting
Harbin Medical University Cancer Hospital Ha’erbin China Not Yet Recruiting
Anhui Provincial Hospital Hefei China Not Yet Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Not Yet Recruiting
The Second Affiliated Hospital of Anhui Medical University Hefei China Not Yet Recruiting
The First Affiliated Hospital of University of South China Hengyang China Recruiting

+ 47 more sites — see the full list on the official registry below.

More Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079983 on ClinicalTrials.gov ↗ ← All trials in China