A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
研究概览
简要总结
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
详细描述
This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
- •Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate renal function
- •Lab values (hematology and chemistry) within institution's normal laboratory limits
- •Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure
- •If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
- •If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits
- •Subject has the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Recurrent ipsilateral breast cancer
- •Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
- •Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
- •History of radiation therapy to ipsilateral breast
- •Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
- •Diagnosis of autoimmune disorders
- •History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
- •History of renal disease or current evidence of renal disease
- •Current diagnosis of any other active or clinically significant non-breast cancer
- •Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
- •Pregnant or breast feeding
研究组 & 干预措施
AVB-620
Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.
干预措施: AVB-620 (Drug)
结局指标
主要结局
Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
时间窗: 30 days
The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.
次要结局
- Characterize the pharmacokinetic profile of AVB-620(8 days)