Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
NCT ID: NCT06942234
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2025-06-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: JSKN016+Paclitaxel
JSKN016 (5mg/kg IV Q3W D1) + nab-paclitaxel (125mg/m² IV Q3W D1, D8)
JSKN016
JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Paclitaxel (albumin bound)
The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Cohort 2: JSKN016+Capecitabine
JSKN016 (5mg/kg IV Q3W D1) + capecitabine (1000mg/m² PO BID Q3W D1-14)
JSKN016
JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Capecitabine
The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.
Cohort 3: JSKN016+Eribulin
JSKN016 (5mg/kg IV Q3W D1) + eribulin (1.4mg/m² IV Q3W D1, D8)
JSKN016
JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Eribulin
The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Cohort 4: JSKN016+Pembrolizumab/Toripalimab
JSKN016 (5mg/kg IV Q3W D1) + pembrolizumab (200mg IV Q3W D1) or toripalimab (240mg IV Q3W D1).
JSKN016
JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Pembrolizumab
The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.
Interventions
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JSKN016
JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Capecitabine
The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.
Paclitaxel (albumin bound)
The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Eribulin
The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Pembrolizumab
The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jian Zhang
Role: primary
Other Identifiers
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JSKN016-202
Identifier Type: -
Identifier Source: org_study_id
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