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

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06079983
• Collaborator: (none)
• Enrollment: 400
• Locations: 50
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: JSKN003; Drug: Capecitabine tablets; Drug: Gemcitabine hydrochloride for injection; Drug: Vinorelbine tartrate injection; Drug: Paclitaxel for injection (albumin-bound type); Drug: Docetaxel injection; Drug: Eribulin mesylate injection	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled TrialA Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JSKN003 Administered intravenously according to protocol.	Drug: JSKN003; Administered intravenously according to protocol.
Active Comparator: The chemotherapy chosen by the investigator The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.	Drug: Capecitabine tablets; Administered according to protocol, as one option for investigator's choice (determined before randomization).; Drug: Gemcitabine hydrochloride for injection; Administered according to protocol, as one option for investigator's choice (determined before randomization).; Drug: Vinorelbine tartrate injection; Administered according to protocol, as one option for investigator's choice (determined before randomization).; Drug: Paclitaxel for injection (albumin-bound type); Administered according to protocol, as one option for investigator's choice (determined before randomization).; Drug: Docetaxel injection; Administered according to protocol, as one option for investigator's choice (determined before randomization).; Drug: Eribulin mesylate injection; Administered according to protocol, as one option for investigator's choice (determined before randomization).

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [16 months 、26 months after the first enrollment]

   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.

Secondary Outcome Measures

1. Overall survival（OS） [16 months 、26months 、60 months after the first enrollment]

   OS, defined as the time from randomization to death from any cause;

2. Objective Response Rate (ORR) [16 months 、26 months after the first enrollment]

   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;

3. Duration of Response (DOR) [16 months 、26 months after the first enrollment]

   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;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.

1. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.

2. 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+.

3. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage.

4. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.

5. Documented radiographic disease progression (during or after the most recent treatment).

6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.

7. 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.

8. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.

9. Have sufficient elution of previous treatment before administration.

Exclusion Criteria:

• 1. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.

1. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration.

2. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.

3. Previous use of anti-HER2 therapeutics, including anti-HER2 antibody conjugates.

4. 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.

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

6. 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).

7. 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.

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erwei Song	Guangzhou	Guangdong	China
2	Jiong Wu	Shanghai	Shanghai	China
3	Anyang Cancer Hospital	Anyang		China
4	Affiliated Hospital of Hebei University	Baoding		China
5	Beijing Luhe Hospital	Beijing		China
6	The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army	Beijing		China
7	Bethune First Hospital of Jilin University	Changchun		China
8	Jilin Provincial Cancer Hospital	Changchun		China
9	Xiangya Hospital, Central South University	Changsha		China
10	West China Hospital, Sichuan University	Chengdu		China
11	Cancer Hospital of Chongqing University	Chongqing		China
12	The First Affiliated Hospital of Chongqing Medical University	Chongqing		China
13	The Second Affiliated Hospital of Dalian Medical University	Dalian		China
14	Fujian Cancer Hospital	Fuzhou		China
15	Union Hospital Affiliated to Fujian Medical University	Fuzhou		China
16	Guangdong Provincial People's Hospital	Guangzhou		China
17	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou		China
18	Sun Yat-sen University Cancer Center	Guanzhou		China
19	Harbin Medical University Cancer Hospital	Ha'erbin		China
20	Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine	Hangzhou		China
21	The First Affiliated Hospital of Zhejiang University School of Medicine	Hanzhou		China
22	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hanzhou		China
23	Zhejiang Cancer Hospital	Hanzhou		China
24	Anhui Provincial Hospital	Hefei		China
25	The First Affiliated Hospital of Anhui Medical University	Hefei		China
26	The Second Affiliated Hospital of Anhui Medical University	Hefei		China
27	Yunnan Cancer Hospital	Kunming		China
28	Gansu Provincial Cancer Hospital	Lanzhou		China
29	Linyi Cancer Hospital	Linyi		China
30	Linyi People's Hospital	Linyi		China
31	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang		China
32	Jiangsu Provincial People's Hospital	Nanjing		China
33	Cancer Hospital Affiliated to Guangxi Medical University	Nanning		China
34	Guangxi Zhuang Autonomous Region People's Hospital	Nanning		China
35	Affiliated Hospital of Qingdao University	Qingdao		China
36	Fudan University Cancer Hospital	Shanghai		China
37	Cancer Hospital Affiliated to Shantou University School of Medicine	Shantou		China
38	The Second Affiliated Hospital of Soochow University	Suzhou		China
39	Shanxi Bethune Hospital	Taiyuan		China
40	Shanxi Provincial Cancer Hospital	Taiyuan		China
41	Hubei Provincial Cancer Hospital	Wuhan		China
42	People's Hospital of Wuhan University	Wuhan		China
43	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan		China
44	Zhongnan Hospital of Wuhan University	Wuhan		China
45	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China
46	The First Affiliated Hospital of Xiamen University	Xiamen		China
47	Xiangyang Central Hospital	Xiangyang		China
48	Affiliated Hospital of Xuzhou Medical University	Xuzhou		China
49	Henan Provincial Cancer Hospital	Zhengzhou		China
50	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China

Sponsors and Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Investigators

• Principal Investigator: Erwei Song, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
• Principal Investigator: Jiong Wu, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• ClinicalTrials.gov Identifier: NCT06079983
• Other Study ID Numbers: JSKN003-302
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Vinorelbine; Docetaxel; Gemcitabine; Capecitabine

Study Results

No Results Posted as of Oct 12, 2023