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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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