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Starting soon Phase 2

A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

NCT07876557 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-10-15
Last updated
2026-10-15

Condition(s) studied

Triple-negative Breast Cancer

Investigational drug(s) / intervention(s)

JS212 in combination with JS207All JS212 trials (8) →All JS207 trials (15) →JS212 monotherapy →JS212 in combination with JS001All JS212 trials (8) →All JS001 trials (37) →

JS212 in combination with JS207: JS212 and JS207 will be administered intravenously on D1, Q3W

JS212 monotherapy: JS212 will be administered intravenously on D1,Q3W

JS212 in combination with JS001: JS212 and JS001 will be administered intravenously on D1, Q3W

Study summary

This is an phase II study to prelininarily evaluate the efficacy and safety of JS212 mono therapy or combination therapy in patients with recurrent or metastatic TNBC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female age 18-70 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(cohort expansion period); only one line of prior systemetic treatment for locally advanced or metastatic TNBC; 5. Adequate organ function; 6. ECOG performance status of 0 or 1; 7. Life expectancy 12 weeks; 8. 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. History of immunodeficiency. Presence of active tuberculosis, hepatitis B, or hepatitis C; 9. Severe cardiovascular disease; 10. Serious infection (CTCAE 6.0 Grade\>2) within 28 days prior to the first dose of study drug; 11. Previous treatment of any anti-VRGF drugs targeting VEGF (part 1) or ADC drugs targeting EGFR and/or HER3; 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)

  • Objective response rate(ORR) — 24 months
    Objective response rate(ORR) evaluated based on RECIST v1.1

Trial sites (29)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian
The First Hospital of Lanzhou University Lanzhou Gansu
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Guangdong General Hospital Guangzhou Guangdong
The Affiliated Cancer Hospital of Guizhou Medical University City: Guiyang Guiyang Guizhou
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
Affiliated Hospital of Hebei University Baoding Hebei
Harbin Medical University Cancer Hospital Harbin Heilongjiang
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Henan Cancer Hospital Zhengzhou Henan
Hubei Cancer Hospital Wuhan Hubei
The First People's Hospital of Changde City Changde Hunan
Hunan Cancer Hospital Changsha Hunan
Jiangsu Province Hospital Nanjing Jiangsu
Nanchang People's Hospital Nanchang Jiangxi
Jilin Provincial Cancer Hospital Changchun Jilin
The First Hospital of Jilin University Changchun Jilin
Shengjing Hospital of China Medical University Shenyang Liaoning
Cancer Hospital of Dalian University of Technology(Liaoning Cancer Hospital & Institute) Shenyang Liaoning
Introduction to the First Affiliated Hospital of China Medical University Shenyang Liaoning
General Hospital of Ningxia Medical University Yinchuan Ningxia
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital) Jinan Shandong
Affiliated Hospital of Jining Medical University Jining Shandong
The Affiliated Hospital of Qingdao University Qingdao Shandong
Weifang People's Hospital Weifang Shandong
Shanxi Cancer Hospital Taiyuan Shanxi
Sichuan Provincial People's Hospital Chengdu Sichuan
Mianyang Central Hospital Mianyang Sichuan
Peking University People's Hospital Beijing China
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 NCT07876557 on ClinicalTrials.gov ↗ ← All trials in China