A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 17
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
详细描述
This is a Phase 2, non-comparative, open-label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
The study includes 2 cohorts, ran in a sequential fashion:
Cohort 1 - AL101 4 mg once weekly (QW) intravenously (IV) Cohort 2 - AL101 6 mg QW IV
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
- •Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
- •Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
- •Patients must have Formalin-fixed, Paraffin-embedded tissue available .
- •Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.
排除标准
- •Diagnosed with a malignancy other than ACC in the past 2 years.
- •Uncontrolled, Active Infection
- •Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
- •Symptomatic central nervous system (CNS) metastases.
- •Unstable or severe uncontrolled medical condition
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥
- •Abnormal organ and marrow function
研究组 & 干预措施
SINGLE-ARM
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
干预措施: AL101 (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 3 years and 7 months
ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Clinical Benefit Response Rate (CBR)(3 years and 7 months)
- Overall Survival(3 years and 5 months)