Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

Exclusion Criteria

• •1. CNS metastasis (except stable cases treated with radiation or surgery).
• •2. Unstable spinal cord compression or untreated history.
• •3. Recent live vaccine (except seasonal flu vaccines).
• •4. Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).
• •5. Recent palliative therapy within 14 days.
• •6. Major surgery within 28 days or planned during the study.
• •7. Severe gastrointestinal issues or recent major GI bleeding.
• •8. Uncontrolled pleural/peritoneal effusions or cachexia.
• •9. Prior HER3/TROP2-targeted therapy or topoisomerase I inhibitors.
• •10. Other malignancies within 5 years (except certain skin or localized cancers).
• •11. Current interstitial lung disease or uncontrolled infections.
• •12. Severe hypercalcemia or uncontrolled cancer-related pain.
• •13. Autoimmune diseases, unless stable with treatment.
• •14. Uncontrolled comorbidities (e.g., active infections, cardiovascular issues).
• •15. Toxicities from previous treatments not resolved to CTCAE ≤1.
• •16. Recent steroid use or need for systemic immunosuppressive therapy.
• •17. Allergy to study drug components.
• •18. Pregnancy or breastfeeding.