RecruitingPhase 2NCT07045311

JS207 Combination Therapy in Triple-negative Breast Cancer

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

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

80 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing JS207, a new drug, in combination with standard chemotherapy for people with triple-negative breast cancer (TNBC) that is advanced or has spread to other parts of the body and has not yet been treated with chemotherapy in the metastatic setting. Triple-negative breast cancer lacks three common receptors, making it harder to treat with hormonal or targeted therapies. **You may be eligible if...** - You are 18–75 years old with confirmed triple-negative breast cancer (no HER2, ER, or PR) - Your cancer is locally advanced (unresectable) or has spread (metastatic) - You have not received chemotherapy specifically for advanced/metastatic TNBC - You have measurable disease on imaging - Your general health score (ECOG) is 0 or 1 (fully active or slightly restricted) **You may NOT be eligible if...** - You have untreated or active brain metastases - You have uncontrolled fluid around the lungs or heart - You have active autoimmune disease - You have had certain prior treatments including anti-PD-1/PD-L1 therapy with short disease-free interval - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJS207 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)

DRUGJS207 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).

Locations(22)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Guangdong women and children's hospital and health institute

Guangzhou, Guangdong, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhangzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanchang People'S Hospital

Nanchang, Jiangxi, China

Jilin University First Hospital

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China

Ceneral Hosipital of Ningxia Medical University

Yinchuan, Ningxia, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Xi'an International Medical Center Hospital

Xian, Shanxi, China

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07045311

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