Status:
RECRUITING
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06079983
Start Date
December 1 2023
End Date
March 1 2029
Last Update
September 12 2025
Active Locations (87)
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1
Erwei Song
Guangzhou, Guangdong, China
2
Jiong Wu
Shanghai, Shanghai Municipality, China
3
Anyang Cancer Hospital
Anyang, China
4
Affiliated Hospital of Hebei University
Baoding, China