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Clinical Trials in China / NCT07045311
Recruiting Phase 2

JS207 Combination Therapy in Triple-negative Breast Cancer

NCT07045311 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Phase
Phase 2
Started
2025-09-17
Last updated
2026-04-15

Condition(s) studied

Triple-negative Breast Cancer

Investigational drug(s) / intervention(s)

JS207 in combination with 9MW2821JS207 in combination with Albumin paclitaxel

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)

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).

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Anhui Provincial Cancer Hospital Hefei Anhui Not Yet Recruiting
Peking University People's Hospital Beijing Beijing Municipality Recruiting
The Fifth Medical Center of PLA General Hospital Beijing Beijing Municipality Recruiting
Guangdong women and children's hospital and health institute Guangzhou Guangdong Not Yet Recruiting
Affiliated Hospital of Hebei University Baoding Hebei Recruiting
Harbin Medical University Affiliated Cancer Hospital Harbin Heilongjiang Not Yet Recruiting
Harbin Medical University Affiliated Cancer Hospital Harbin Heilongjiang Not Yet Recruiting
Henan Cancer Hospital Zhangzhou Henan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Jiangsu Cancer Hospital Nanjing Jiangsu Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
Nanchang People'S Hospital Nanchang Jiangxi Not Yet Recruiting
Jilin University First Hospital Changchun Jilin Recruiting
The Second Hospital of Dalian Medical University Dalian Liaoning Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Liaoning Cancer Hospital&Institute Shenyang Liaoning Recruiting
Ceneral Hosipital of Ningxia Medical University Yinchuan Ningxia Not Yet Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xian Shanxi Recruiting
Xi'an International Medical Center Hospital Xian Shanxi Recruiting
Affiliated Tumor Hospital of Xinjiang Medical University Ürümqi Xinjiang Uygur Autonomous Region Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Shanghai Junshi Bioscience Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07045311 on ClinicalTrials.gov ↗ ← All trials in China