Actively Recruiting
Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2025-09-17
180
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Age between 18 and 75 years
- Confirmed inoperable locally advanced or metastatic HER2-negative breast cancer
- Hormone receptor-positive with progression or intolerance after endocrine therapy, or unsuitable for it
- Radiological evidence of disease progression after systemic treatment
- Available tumor tissue or biopsy sample
- No prior systemic therapy for advanced disease except endocrine therapy or CDK4/6 inhibitors
- Measurable non-CNS lesion by RECIST 1.1
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Agreement to use contraception if fertile
- Adequate organ function within 7 days before enrollment including bone marrow, liver, kidney, and coagulation
- Left ventricular ejection fraction of 50% or higher
You will not qualify if you...
- Central nervous system metastases except stable cases treated with radiation or surgery
- Unstable or untreated spinal cord compression
- Recent live vaccine except seasonal flu vaccine
- Anti-tumor treatment within 28 days or 5 half-lives, whichever is shorter
- Palliative therapy within 14 days
- Major surgery within 28 days or planned during the study
- Severe gastrointestinal disorders or recent major gastrointestinal bleeding
- Uncontrolled pleural or peritoneal effusions or severe cachexia
- Prior therapy targeting HER3/TROP2 or topoisomerase I inhibitors
- Other malignancies within 5 years except certain localized or skin cancers
- Current interstitial lung disease or uncontrolled infections
- Severe hypercalcemia or uncontrolled cancer pain
- Autoimmune diseases unless stable with treatment
- Uncontrolled comorbidities such as active infections or cardiovascular issues
- Unresolved toxicities from previous treatments greater than CTCAE grade 1
- Recent steroid use or need for systemic immunosuppressive therapy
- Allergy to components of study drugs
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer center
Shanghai, China
Actively Recruiting
Research Team
J
Jian Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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