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

Launched by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JSKN016 for patients with HER2-negative breast cancer that cannot be surgically removed or has spread to other parts of the body. The main goal is to see how safe and effective this treatment is when combined with either chemotherapy or immunotherapy. The study will involve different groups of patients, each with specific treatment histories and tumor characteristics, to better understand how well the treatment works for various individuals.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed diagnosis of inoperable locally advanced or metastatic HER2-negative breast cancer. They should not have received certain types of previous treatments for their advanced cancer. Participants will be closely monitored throughout the trial and may undergo tests to evaluate their response to the treatment and any side effects. It's important to note that the trial is not yet recruiting participants, so those interested will need to wait for the study to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Capable of understanding and signing the informed consent form.
• • 2. Aged ≥18 and ≤75 years, regardless of sex.
• • 3. Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.
• • 4. Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.
• • 5. Disease progression confirmed by radiological evidence post-systemic treatment.
• • 6. Available archived or newly obtained tumor tissue/biopsy.
• • 7. No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4/6 inhibitors.
• • 8. Measurable non-CNS lesion per RECIST 1.1.
• • 9. Expected survival ≥3 months.
• • 10. ECOG performance status of 0 or 1.
• • 11. Contraceptive use agreement for fertile participants.
• 12. Adequate organ function within 7 days of enrollment:
• • Bone marrow: ANC ≥1.5 × 10⁹/L, Hemoglobin ≥90 g/L, Platelets ≥100 × 10⁹/L.
• • Liver: Bilirubin ≤1.5 × ULN, ALT/AST ≤3 × ULN.
• • Renal: Creatinine ≤1.5 × ULN or Ccr ≥60 mL/min.
• • Coagulation: INR/PT ≤1.5 × ULN, APTT ≤1.5 × ULN.
• • 13. LVEF ≥50%.
• 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.