A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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;
You may not be if
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;
Clareo Health | A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
