NCT07299825RecruitingPhase 2
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 20 Sept 2024
- Primary completion date
- 20 Sept 2027
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07299825
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 20 Sept 2024 to the primary completion date, 20 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
- Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
Other illness
- Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
- Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
- Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
Other
- Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
Who the study is looking for
- Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
- Breast cancer patients by histopathology and/or cytology documented.
- In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.
- Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
- At least one measurable lesion according to RECIST 1.1 criteria.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Provincial Cancer Hospital Coordinator of this site? Confirm its status | Zhenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.