Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
详细描述
This study will evaluate the efficacy of A166 in patients with HER2-positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates.
A166 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
A166
A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).
干预措施: A166 (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: Within 24 months of last patient enrolled
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1
Objective response rate(ORR)
时间窗: Within 24 months of last patient enrolled
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1
次要结局
- Progression-free survival (PFS)(Within 24 months of last patient enrolled)
- Overall survival (OS)(Within 48 months of last patient enrolled)
- Disease control rate(DCR)(Within 24 months of last patient enrolled)
- Duration of response(DOR)(Within 24 months of last patient enrolled)
- Clinical Benefit Rate (CBR)(Within 24 months of last patient enrolled)
- Progression-free survival (PFS)(Within 24 months of last patient enrolled)
- Overall survival (OS)(Within 48 months of last patient enrolled)
- Disease control rate(DCR)(Within 24 months of last patient enrolled)
- Duration of response(DOR)(Within 24 months of last patient enrolled)
- Clinical Benefit Rate (CBR)(Within 24 months of last patient enrolled)