Overview
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.
Description
The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.
Eligibility
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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；