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
- 6
- 试验地点
- 1
- 主要终点
- Adverse event
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 MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort.
详细描述
Objectives:
Primary objective:
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
Secondary objective:
To determine the pharmacokinetics (PK) characteristics of MEDI9447 To determine the immunogenicity of MEDI9447 To evaluate candidate biomarker of MEDI9447 activity in archival tumor biopsy specimens To describe the preliminary antitumor activity of MEDI9447
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects; age ≥ 20 years
- •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
- •Adequate organ function
- •Body weight ≥ 35 kg
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 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 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
研究组 & 干预措施
MEDI9447 monotherapy
Dose escalation of MEDI9447 monotherapy for patients with advanced solid malignancies
干预措施: MEDI9447 (oleclumab) (Drug)
结局指标
主要结局
Adverse event
时间窗: From the informed consent to 90 days after the last dose
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
次要结局
未报告次要终点