NCT03394144已完成1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety and tolerability in terms of adverse events
研究概览
简要总结
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.
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
- 20 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients must be at least 20 years of age.
- •Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or
- •Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
- •Adequate organ and marrow function
- •Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
排除标准
- •Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
- •Patients must have completed any previous cancer-related treatments before enrolment.
- •Has active or prior autoimmune disease within the past 2 years
- •Has active or prior inflammatory bowel disease or primary immunodeficiency
- •Undergone an organ transplant that requires use of immunosuppressive treatment
- •Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
- •Prior exposure to AZD9150 or any other anti PD (L)1 antibody.
研究组 & 干预措施
C1:AZD9150, C2:AZD9150+Durvalumab
Experimental
After confirmed safety with Cohort 1, Cohort 2 will open
干预措施: AZD9150, Durvalumab (Drug)
结局指标
主要结局
Safety and tolerability in terms of adverse events
时间窗: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
次要结局
- Maximum plasma concentration (Cmax)(From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.)
- Overall response rate(Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.)
- Duration of Response(Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.)
- Area under the plasma concentration-time curve (AUC)(From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.)
研究者
研究点 (1)
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