Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07045311

JS207 Combination Therapy in Triple-negative Breast Cancer

Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-04-15

80

Participants Needed

22

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

JS207 Combination Therapy in Triple-negative Breast Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 years
  • Voluntary participation in the clinical study
  • Histologically confirmed unresectable, locally advanced, or metastatic triple-negative breast cancer (no HER2, ER, or PR expression)
  • No prior systemic antitumor therapy for locally advanced or metastatic TNBC
  • Prior neoadjuvant or adjuvant systemic anti-tumor therapy allowed if recurrence/metastasis occurred at least 6 months after therapy; if taxane was used, disease-free interval must be at least 12 months
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Measurable disease as defined by RECIST v1.1
Not Eligible

You will not qualify if you...

  • Untreated or active central nervous system (CNS) metastases
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Tumor encasement of important vessels or significant necrosis and cavitation posing hemorrhage risk
  • History of significant bleeding tendency or severe coagulation disorder
  • Uncontrolled hypertension
  • Active autoimmune diseases requiring systemic treatment within 2 years prior to first dose
  • History of interstitial lung disease, previous noninfectious pneumonitis treated with corticosteroids, or active pneumonia seen on screening radiology
  • Severe eye disorders or symptoms such as xerophthalmia or keratoconjunctivitis sicca
  • Severe cardiovascular disease
  • Serious infection (CTCAE grade greater than 2) within 28 days prior to first dose
  • Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or agents targeting other T cell receptors in (neo)adjuvant therapy unless disease-free interval is at least 6 months
  • Prior treatment with antibody-drug conjugates linked to MMAE or targeting Nectin-4, such as Enfortumab Vedotin, is not allowed
  • History of another malignancy within 5 years prior to first dose
  • Any condition making participant unsuitable for study treatment as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China, 230000

Not Yet Recruiting

2

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

3

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China, 100071

Actively Recruiting

4

Guangdong women and children's hospital and health institute

Guangzhou, Guangdong, China, 511400

Not Yet Recruiting

5

Affiliated Hospital of Hebei University

Baoding, Hebei, China, 071030

Actively Recruiting

6

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China, 150001

Not Yet Recruiting

7

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China, 150001

Not Yet Recruiting

8

Henan Cancer Hospital

Zhangzhou, Henan, China, 450003

Actively Recruiting

9

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

10

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China, 210009

Actively Recruiting

11

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Not Yet Recruiting

12

Nanchang People'S Hospital

Nanchang, Jiangxi, China, 330000

Not Yet Recruiting

13

Jilin University First Hospital

Changchun, Jilin, China, 130021

Actively Recruiting

14

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China, 116027

Actively Recruiting

15

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

16

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China, 110801

Actively Recruiting

17

Ceneral Hosipital of Ningxia Medical University

Yinchuan, Ningxia, China, 750000

Not Yet Recruiting

18

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266035

Actively Recruiting

19

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China, 710061

Actively Recruiting

20

Xi'an International Medical Center Hospital

Xian, Shanxi, China, 710100

Actively Recruiting

21

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000

Actively Recruiting

22

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Not Yet Recruiting

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Research Team

C

Chaoqiang Yang, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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JS207 Combination Therapy in Triple-negative Breast Cancer | DecenTrialz