RecruitingPhase 2

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

China40 participantsStarted 2024-09-20

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Objective response rate(ORR)

Timeframe: Within 24 months of last patient enrolled

Trial details

NCT IDNCT07299825

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-20

Contact for this trial

Min Yan, Professor

0371-65588404 ym200678@126.com

View on ClinicalTrials.gov More Her 2 Positive Breast Cancer trials