NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Disease Progression
研究概览
简要总结
The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.
详细描述
Treatment:
Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.
Clinic Visits:
On Day 1 of Cycle 1 and then every 3 weeks from then on:
- Participant will have a physical exam
- Blood (about 3 teaspoons) will be drawn for routine tests.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal.
- •Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression
- •Capability to understand and comply with the protocol and signed informed consent document.
排除标准
- •Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
- •Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.
研究组 & 干预措施
Brontictuzumab
1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.
干预措施: Brontictuzumab (Drug)
结局指标
主要结局
Number of Participants With Disease Progression
时间窗: 6 weeks
Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
未报告次要终点