NCT05346328尚未招募2 期
An Open-clinical Trial Phase Ⅱ, Injection of A166 for HER2-positive Patients With Refractory Unresectable Locally Advanced or Metastatic Breast Cancer；KL166-IIS-001
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Objective response rate（ORR）
研究概览
简要总结
This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.
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, including:
- •a) Participants with unresectable locally advanced or metastatic breast cancer; b) Evaluated or tested as HER2-positive expression. The definition of HER2 positive in this study: immunohistochemistry (IHC) was 2+ and confirmed by fluorescence in situ hybridization (FISH), or IHC was 3+;
- •Have received at least 3 targeted therapies for locally advanced or metastatic disease, including:
- •Disease progression after receiving at least 1 trastuzumab-containing (including a biosimilar of trastuzumab on the market)-based treatment;
- •After receiving at least one anti-HER2 tyrosine kinase inhibitor (lapatinib or pyrrotinib)-based treatment plan, the disease progresses or cannot tolerate toxic and side effects;
- •The disease progresses or cannot tolerate toxic and side effects after receiving treatment with antibody-conjugated drugs targeting HER2 (such as T-DM1 or other ADCs); Note: Adjuvant therapy and anti-HER2 therapy used in the neoadjuvant treatment stage before radical treatment are not counted, but recurrence or metastasis occurs during the last anti-HER2 medication period or within one year after the end, it can be regarded as a plan.
- •Have previously received taxanes to treat breast cancer;
排除标准
- •Serious or uncontrollable heart diseases that require treatment, including:
- •Congestive heart failure graded 3 or 4 by the New York College of Cardiology (NYHA);
- •Unstable angina pectoris that cannot be controlled by drugs;
- •Myocardial infarction occurred within 6 months before the first administration of the study treatment;
- •Severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia);
- •Baseline measurement, QTc interval, male> 450 msec, female> 470 msec;
- •Clinically active interstitial lung disease;
- •Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that have failed local treatment; for asymptomatic brain metastases, or with stable clinical symptoms and no need for steroids and other brain metastases within 4 weeks before the first administration of the trial drug Treated patients can be included in the group;
- •Those who are known to have a history of hypersensitivity to other monoclonal antibodies or allergic to A166 and its components for injection;
- •Those who have permanently discontinued trastuzumab due to any toxicity;
研究组 & 干预措施
Single Group Assignment
Experimental
This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.
干预措施: Injection of A166 (Drug)
结局指标
主要结局
Objective response rate（ORR）
时间窗: 2 years
ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1.
次要结局
- Progression-free survival(PFS)(2 years)
- Clinical benefit rate(CBR)(2 years)
- Duration of rate(DOR)(2 years)
- Overall survival(OS)(2 years)
- Disease control rate(DCR)(2 years)
- Time to response(TTR)(2 years)
研究者
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