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

Recruiting now · Phase 1/Phase 2

Conditions studied: Inoperable Locally Advanced HER2-Negative Breast Cancer, Metastatic HER2-Negative Breast Cancer

In brief

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.

Key facts

Study ID

NCT06942234

Run by

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

People needed

180

Starts

2025-06-01

Expected to finish

2027-12-31

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of understanding and signing the informed consent form.
• Aged ≥18 and ≤75 years, regardless of sex.
• Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.
• Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.
• Disease progression confirmed by radiological evidence post-systemic treatment.
• Available archived or newly obtained tumor tissue/biopsy.
• No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4/6 inhibitors.
• Measurable non-CNS lesion per RECIST 1.1.
• Expected survival ≥3 months.
• ECOG performance status of 0 or 1.
• Contraceptive use agreement for fertile participants.
• 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.
• LVEF ≥50%.

You may not qualify if…

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

Where it is running

• Fudan University Shanghai Cancer center — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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