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Recruiting Phase 2

A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

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About this study

Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates

Condition
Her 2 Positive Breast Cancer
Tested
A166
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Her 2 Positive Breast Cancer
  • 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 6

  • 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.

Where

1 site, 1 recruiting

Henan Provincial Cancer Hospital

Zhenzhou, Henan, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.