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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079983
• Other study ID #: JSKN003-302
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: March 1, 2029

Study information

• Verified date: September 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: Erwei Song
• Phone: 020-81332507
• Email: songew[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 1, 2029
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang
China	Affiliated Hospital of Hebei University	Baoding
China	Beijing Luhe Hospital	Beijing
China	The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army	Beijing
China	Bethune First Hospital of Jilin University	Changchun
China	Jilin Provincial Cancer Hospital	Changchun
China	Xiangya Hospital, Central South University	Changsha
China	West China Hospital, Sichuan University	Chengdu
China	Cancer Hospital of Chongqing University	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The Second Affiliated Hospital of Dalian Medical University	Dalian
China	Fujian Cancer Hospital	Fuzhou
China	Union Hospital Affiliated to Fujian Medical University	Fuzhou
China	Erwei Song	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou
China	Sun Yat-sen University Cancer Center	Guanzhou
China	Harbin Medical University Cancer Hospital	Ha'erbin
China	Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hanzhou
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hanzhou
China	Zhejiang Cancer Hospital	Hanzhou
China	Anhui Provincial Hospital	Hefei
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	The Second Affiliated Hospital of Anhui Medical University	Hefei
China	Yunnan Cancer Hospital	Kunming
China	Gansu Provincial Cancer Hospital	Lanzhou
China	Linyi Cancer Hospital	Linyi
China	Linyi People's Hospital	Linyi
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang
China	Jiangsu Provincial People's Hospital	Nanjing
China	Cancer Hospital Affiliated to Guangxi Medical University	Nanning
China	Guangxi Zhuang Autonomous Region People's Hospital	Nanning
China	Affiliated Hospital of Qingdao University	Qingdao
China	Fudan University Cancer Hospital	Shanghai
China	Jiong Wu	Shanghai	Shanghai
China	Cancer Hospital Affiliated to Shantou University School of Medicine	Shantou
China	The Second Affiliated Hospital of Soochow University	Suzhou
China	Shanxi Bethune Hospital	Taiyuan
China	Shanxi Provincial Cancer Hospital	Taiyuan
China	Hubei Provincial Cancer Hospital	Wuhan
China	People's Hospital of Wuhan University	Wuhan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Zhongnan Hospital of Wuhan University	Wuhan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Xiangyang Central Hospital	Xiangyang
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Henan Provincial Cancer Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.	16 months ?26 months after the first enrollment
Secondary	Overall survival(OS)	OS, defined as the time from randomization to death from any cause;	16 months ?26months ?60 months after the first enrollment
Secondary	Objective Response Rate (ORR)	BICR and investigators were judged according to RECIST v1.1 criteria ,objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria;	16 months ?26 months after the first enrollment
Secondary	Duration of Response (DOR)	BICR and investigators were judged according to RECIST v1.1 criteria,Duration of response (DoR), defined as the time from the first recorded response (CR/PR) to the first documented disease progression (PD) or death from any cause;	16 months ?26 months after the first enrollment