Overview
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.
Description
The study consists of 2 parts. Both parts consist of safety run-in period and cohort expansion period. Safety run-in period will enroll those who have received only 1 line of prior systemic standard treatment. Cohort expansion period will enroll those are treated naive or recived treatment in adjuvant phase.
Part 1 will receive JS212 monotherapy or combination therapy with JS207, based on the PD-L1 expression. Part 2 will receive JS212 in combination with JS001.
Eligibility
Inclusion Criteria:
- Male or female age 18-70 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（cohort expansion period); only one line of prior systemetic treatment for locally advanced or metastatic TNBC;
- 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;
- History of immunodeficiency. Presence of active tuberculosis, hepatitis B, or hepatitis C;
- Severe cardiovascular disease;
- Serious infection (CTCAE 6.0 Grade\>2) within 28 days prior to the first dose of study drug;
- Previous treatment of any anti-VRGF drugs targeting VEGF (part 1) or ADC drugs targeting EGFR and/or HER3;
- 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;
