jRCT2080224133已完成1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients with Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single-arm, Open Label
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adult subjects; age 20 years or more
- •Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists
- •Subjects must have at least 1 lesion that is measureable using RECIST v1.1
- •All subjects must consent to provide archived tumor specimens for biomarker studies
- •ECOG Performance Status of 0 or 1
- •Life expectancy 12 weeks or more
- •Adequate organ function
- •Body weight 35 kg or more
排除标准
- •Patients must have completed any previous cancer-related treatments before enrollment
- •Prior treatment with CD73 antagonist, tumor necrosis factor receptor superfamily agonists
- •All CTLA-4, PD-1, or PD-L1 antagonists related-AEs must have resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to screening and not worsened before the first dose of study drug
- •Must not have required the use of additional immunosuppression other than corticosteroids for the management of an CTLA-4, PD-1, or PD-L1 related AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
- •Known allergy or hypersensitivity to the study drug, its compounds, or agents similar biologic composition
- •History of more than one event of IRR requiring permanent discontinuation of IV drug treatment
- •History of severe drug allergies or anaphylaxis to 2 or more food products or medicine
- •Cardiac or peripheral vascular disease
- •NCI CTCAE v4.03 Grade 3 or greater edema
- •Uncontrolled massive ascites or pleural effusion
- •History of NCI CTCAE v4.03 Grade 3 or greater thromboembolic events within 3 months prior to the first dose of study drug or thromboembolic event of any grade with ongoing symptoms
- •Active tuberculosis
- •Patients with history of, or current ILD
- •Active or prior documented autoimmune within the past 3 years prior to the start of treatment
- •Untreated or unstable CNS metastatic disease, leptomeningeal disease, or cord compression
- •Concurrent enrollment in another clinical study
- •Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- •Toxicities from prior anticancer therapy that have not resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to the first dose of study drug
- •History of primary immunodeficiency or solid organ transplantation
- •Active hepatitis B, hepatitis C, or HIV
- •Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
- •Other invasive malignancy within 2 years prior to the first dose of study drug
- •Uncontrolled concomitant illnes
- •Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
- •Involvement in the planning and/or conduct of the study
结局指标
主要结局
-
safety -
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients with Advanced Solid MalignanciesAdvanced Solid MalignanciesJPRN-jRCT2080224133AstraZeneca12
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 MalignanciesAdvanced Solid MalignanciesJPRN-jRCT2080223819AstraZeneca KK9
已完成
1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid MalignanciesAdvanced Solid MalignanciesJPRN-jRCT2080224739AstraZeneca KK12
暂停
1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-Tumour Activity of Adavosertib (AZD1775) in Japanese Patients with Advanced Solid TumoursAdvanced Solid TumoursJPRN-jRCT2080225236AstraZeneca KK12
已完成
1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid MalignanciesjRCT2080224739AstraZeneca KK12