Actively Recruiting
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
CONDITIONS
Official Title
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient aged 18 to 75 years at informed consent
- Histopathology or cytology confirmed breast cancer
- Advanced or metastatic breast cancer with no more than 5 lines of systemic therapy
- At least one prior treatment includes a HER2 ADC with a topoisomerase inhibitor payload
- Disease progression or intolerance during or after the most recent treatment
- At least one measurable lesion according to RECIST 1.1 criteria
You will not qualify if you...
- Previous treatment with A166 or any HER2-targeted ADC with a microtubule inhibitor payload
- History of severe hypersensitivity to monoclonal antibodies or allergy to A166 components
- Permanent discontinuation of trastuzumab or biosimilars due to toxicity
- Severe corneal epithelial disease or inability to perform daily activities without contact lenses
- Presence of spinal cord compression or active central nervous system metastases
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Provincial Cancer Hospital
Zhenzhou, Henan, China, 450000
Actively Recruiting
Research Team
M
Min Yan, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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