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JSKN016 in combination therapy for HER2-negative breast cancer
NCT06942234Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Alphamab Oncology
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- JSKN016
- Conditions
- breast cancer
01
Overview
Phase 2, open-label trial of JSKN016 in breast cancer (4 cohorts), sponsored by Alphamab Oncology. Primary endpoint: Objective Response Rate at 24 months. Started Jun 2025; status: recruiting.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Cohort 1: JSKN016+Paclitaxel
JSKN016 in combination with nab-paclitaxel
Cohort 2: JSKN016+Capecitabine
JSKN016 in combination with capecitabine
Cohort 3: JSKN016+Eribulin
JSKN016 in combination with eribulin
Cohort 4: JSKN016+Pembrolizumab/Toripalimab
JSKN016 in combination with pembrolizumab or toripalimab
03
Who it enrols
Adults aged 18-75 with histologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer, ECOG 0-1, no prior systemic therapy for advanced disease (except endocrine ± targeted therapy or CDK4/6 inhibitors), measurable disease per RECIST 1.1, adequate organ function, and no prior HER3/TROP2-targeted therapy or topoisomerase I inhibitors
04
Endpoints
Primary
Objective Response Rate
Secondary
Duration of Response
Disease Control Rate
Progression-Free Survival
Overall Survival
Adverse Events
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