JPRN-jRCT2080223819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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
- •- 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.
研究者
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