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New treatment option for Inoperable Locally Advanced HER2-Negative Breast Cancer
Official title Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06942234
What this study is testing
What is JSKN016?
JSKN016 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for inoperable locally advanced her2-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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.
See the full eligibility criteria
- 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%.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.