Clinical trial NCT06079983: JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Official title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial
Primary purpose: TREATMENT

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 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 400 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

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 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 400 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 criteria: 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 anti-HER2 therapeutics, including anti-HER2 antibody conjugates.

  6. Previous use of antibody conjugates containing topoisomerase I inhibitors. 7. There is a third gap fluid that cannot be controlled by drainage, etc. 8. Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy.

  9. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.

  10. Previous or current autoimmune disease. 11. Have uncontrolled comorbidities. 12. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0).

  13. History of previous immunodeficiency. 14. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation.

  15. 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 outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 16 months 、26 months after the first enrollment
Secondary outcomes:
measure: Overall survival（OS）
timeFrame: 16 months 、26months 、60 months after the first enrollment
measure: Objective Response Rate (ORR)
timeFrame: 16 months 、26 months after the first enrollment
measure: Duration of Response (DOR)
timeFrame: 16 months 、26 months after the first enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Erwei Song
state: Guangdong
city: Shanghai
country: China
facility: Jiong Wu
state: Shanghai
city: Anyang
country: China
facility: Anyang Cancer Hospital
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Beijing Luhe Hospital
city: Beijing
country: China
facility: The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Provincial Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Cancer Hospital of Chongqing University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Fuzhou
country: China
facility: Union Hospital Affiliated to Fujian Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Ha'erbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hangzhou
country: China
facility: Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
city: Hanzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
city: Hanzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hanzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Linyi
country: China
facility: Linyi People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
city: Nanning
country: China
facility: Cancer Hospital Affiliated to Guangxi Medical University
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Shantou
country: China
facility: Cancer Hospital Affiliated to Shantou University School of Medicine
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Wuhan
country: China
facility: Hubei Provincial Cancer Hospital
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
city: Zhengzhou
country: China
facility: Henan Provincial Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Erwei Song
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jiong Wu
role: PRINCIPAL_INVESTIGATOR
References: