A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
NCT ID: NCT07299825
Last Updated: 2025-12-23
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
PHASE2
40 participants
INTERVENTIONAL
2024-09-20
2027-12-31
Brief Summary
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Detailed Description
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A166 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A166
A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).
A166
intravenous(IV) infusion (Q3W)
Interventions
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A166
intravenous(IV) infusion (Q3W)
Eligibility Criteria
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Inclusion Criteria
2. Breast cancer patients by histopathology and/or cytology documented.
3. 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.
4. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
5. At least one measurable lesion according to RECIST 1.1 criteria.
Exclusion Criteria
2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Henan Provincial Cancer Hospital
Zhenzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Min Yan, Professor
Role: primary
Other Identifiers
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KL166-II-08
Identifier Type: -
Identifier Source: org_study_id