RecruitingPhase 2NCT07299825
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
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Enrollment
40 participants
Start Date
Sep 20, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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.
Exclusion Criteria6
- Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
- Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
- Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
- Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
- Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
- Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
Interventions
DRUGA166
intravenous(IV) infusion (Q3W)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07299825