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A166 in HER2-positive Metastatic Breast Cancer Previously Treated With TOP1-ADCs
NCT07299825Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2024
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Kelun-Biotech
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of trastuzumab botidotin in breast cancer, sponsored by Kelun-Biotech. Primary endpoint: Objective Response Rate at 24 months. Started Sep 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
A166
A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).
03
Who it enrols
Patients aged 18-75 with HER2-positive advanced/metastatic breast cancer who received <=5 prior lines of systemic therapy including a HER2 ADC with a topoisomerase inhibitor, and experienced disease progression or intolerance. Excludes prior treatment with A166 or HER2 ADCs with microtubule inhibitors, and active CNS metastases.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Overall Survival
Disease Control Rate
Duration of Response
Clinical Benefit Rate
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