JS207 Combination Therapy in Triple-negative Breast Cancer

April 10, 2026 updated by: Shanghai Junshi Bioscience Co., Ltd.

JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yueyin Pan, Doctor
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Shu Wang, Doctor
        • Principal Investigator:
          • Shu Wang, Doctor
      • Beijing, Beijing Municipality, China, 100071
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Principal Investigator:
          • Zefei Jiang, Doctor
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Not yet recruiting
        • Guangdong women and children's hospital and health institute
        • Contact:
        • Principal Investigator:
          • Anqin Zhang, Doctor
    • Hebei
      • Baoding, Hebei, China, 071030
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Principal Investigator:
          • Hua Yang
        • Contact:
          • Hua Yang, Doctor
          • Phone Number: 18603120729
          • Email: docgh@163.com
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • Harbin Medical University Affiliated Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Li Cai, Doctor
    • Henan
      • Zhangzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Min Yan, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xinhong Wu, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Sainan Hu, Doctor
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Yongmei Yin, Doctor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • Nanchang People's Hospital
        • Contact:
        • Principal Investigator:
          • Wenyan Chen, Doctor
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Jilin University First Hospital
        • Contact:
        • Principal Investigator:
          • Zheng Lv, Doctor
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Principal Investigator:
          • Man Li, Doctor
        • Contact:
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital&Institute
        • Principal Investigator:
          • Tao Sun, Doctor
        • Contact:
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Yuee Teng, Doctor
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Not yet recruiting
        • Ceneral Hosipital of Ningxia Medical University
        • Contact:
        • Principal Investigator:
          • Ye LV, Master
    • Shandong
      • Qingdao, Shandong, China, 266035
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Principal Investigator:
          • Haibo Wang, Doctor
        • Contact:
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Principal Investigator:
          • Jin Yang, Doctor
      • Xian, Shanxi, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
        • Principal Investigator:
          • Yan Xue, Doctor
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
        • Recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Principal Investigator:
          • Bing Zhao, Doctor
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Yiding Chen, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female age 18 - 75 years old；
  2. Voluntary participation in clinical study；
  3. Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
  4. No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
  5. Prior use of systemic anti-tumor therapy in the neoadjuvant and/or adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant/adjuvant therapy and the occurrence of recurrence/metastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant/adjuvant phase, the DFI must be ≥12 months;
  6. Adequate organ function;
  7. ECOG performance status of 0 or 1;
  8. Life expectancy 12 weeks;
  9. Measurable disease, as defined by RECIST v1.1;

Exclusion Criteria:

  1. Untreated or active central nervous system (CNS) metastases；
  2. Uncontrolled pleural effusion, pericardial effusion or ascites；
  3. Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；
  4. History of significant bleeding tendency or severe coagulation disorder；
  5. Uncontrolled hypertension；
  6. Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；
  7. History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；
  8. Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
  9. Severe cardiovascular disease；
  10. Serious infection (CTCAE 5.0 Grade>2) within 28 days prior to the first dose of study drug；
  11. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) in (new) adjuvant therapy is allowed, if DFI is ≥6 months previously treated with Antibody-Drug Conjugates conjugated with MMAE and/or targeting Nectin-4, such as Enfortumab Vedotin is not allowed；
  12. History of another malignancy within 5 years before the first dose of study drug；
  13. Not suitable to receive study treatment for other conditions as per investigator；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort B
Drug: JS207 in combination with Albumin paclitaxel
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W).
Experimental: Cohort A
Drug: JS207 in combination with 9MW2821
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 2years
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
2years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR
Time Frame: 2years
Duration of response (DoR) evaluated based on RECIST v1.1
2years
DCR
Time Frame: 2years
Disease control rate (DCR) evaluated based on RECIST v1.1
2years
PFS
Time Frame: 2years
Progression-free survival (PFS) evaluated based on RECIST v1.1
2years
OS
Time Frame: 3years
The time from first dose to death from any cause
3years
AE
Time Frame: 2years
Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v5.0
2years
Plasma concentrations
Time Frame: 2years
Plasma concentrations of JS207 and 9MW2821.
2years
ADA
Time Frame: 2years
The incidence and titer of anti-drug antibodies (ADA) of JS207 and 9MW2821
2years
Nab
Time Frame: 2years
The incidence of Nab(if applicable) of JS207 and 9MW2821
2years
PD-L1
Time Frame: 2years
The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy
2years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nectin-4 expression
Time Frame: 2years
The correlation between Nectin-4 expression in tumor tissue and therapeutic efficacy
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

March 22, 2028

Study Completion (Estimated)

March 22, 2029

Study Registration Dates

First Submitted

June 23, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Actual)

July 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS207-008-II-TNBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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