JS207 Combination Therapy in Triple-negative Breast Cancer

Prior treatment

• 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；
• 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；

Other illness

• 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；
• Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
• Severe cardiovascular disease；
• 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；

Other

• Untreated or active central nervous system (CNS) metastases；
• Uncontrolled pleural effusion, pericardial effusion or ascites；

• 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;