JS207 Combination Therapy in Triple-negative Breast Cancer

Recruiting now · Phase 2

Conditions studied: Triple-negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT07045311

Run by

Shanghai Junshi Bioscience Co., Ltd.

People needed

80

Starts

2025-09-17

Expected to finish

2029-03-22

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age 18 - 75 years old；
• Voluntary participation in clinical study；
• Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
• No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
• 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;
• Adequate organ function;
• ECOG performance status of 0 or 1;
• Life expectancy 12 weeks;
• Measurable disease, as defined by RECIST v1.1;

You may not qualify if…

• 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 that may cause a risk of hemorrhage；
• History of significant bleeding tendency or severe coagulation disorder；
• Uncontrolled hypertension；
• Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；
• History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；
• Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
• Severe cardiovascular disease；
• Serious infection (CTCAE 5.0 Grade>2) within 28 days prior to the first dose of study drug；
• 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；
• History of another malignancy within 5 years before the first dose of study drug；
• Not suitable to receive study treatment for other conditions as per investigator；

Where it is running

• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Liaoning Cancer Hospital&Institute — Shenyang, Liaoning, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xian, Shanxi, China (enrolling)
• Xi'an International Medical Center Hospital — Xian, Shanxi, China (enrolling)
• Affiliated Tumor Hospital of Xinjiang Medical University — Ürümqi, Xinjiang Uygur Autonomous Region, China (enrolling)
• Henan Cancer Hospital — Zhangzhou, Henan, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (enrolling)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (enrolling)
• The Fifth Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Jilin University First Hospital — Changchun, Jilin, China (enrolling)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (enrolling)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Guangdong women and children's hospital and health institute — Guangzhou, Guangdong, China
• Harbin Medical University Affiliated Cancer Hospital — Harbin, Heilongjiang, China
• Harbin Medical University Affiliated Cancer Hospital — Harbin, Heilongjiang, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• Nanchang People'S Hospital — Nanchang, Jiangxi, China
• Ceneral Hosipital of Ningxia Medical University — Yinchuan, Ningxia, China
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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