JPRN-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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
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
- •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
研究者
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