Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07299825

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Henan Provincial Cancer Hospital

Zhenzhou, Henan, China, 450000

Actively Recruiting

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