NCT01765790已完成1 期
A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors
Baxalta now part of Shire10 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2012年6月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 10
- 主要终点
- Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Males and females 18 years of age and older at the time of screening
- •Anticipated life expectancy > 3 months at the time of screening
- •Arm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
- •Arm 2 only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
- •Measurable or evaluable disease (as defined in the study protocol)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Adequate hematological function (as defined in the study protocol)
- •Adequate renal function (as defined in the study protocol)
- •Adequate liver function (as defined in the study protocol)
- •Adequate venous access
- •Arm 2 only: At least 1 tumor that is amenable to biopsy, as determined by the investigator, and participant must be willing to undergo a biopsy prior to and at least once following anti-macrophage migration inhibitory factor (anti-MIF) antibody treatment
- •For women of childbearing potential, the participant must have a negative pregnancy test at screening and must agree to employ 2 forms of adequate contraceptive measures
- •For males, participants must agree to use adequate contraceptive measures including at least 1 barrier method, and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of investigational product.
- •Participant is willing and able to comply with the requirements of the protocol
排除标准
- •Known brain tumors or Central nervous system (CNS) metastases
- •Myocardial infarction within 6 months of anti-MIF antibody administration, congestive heart failure (New York Heart Association Class III or Class IV), unstable angina, unstable cardiac arrhythmia requiring medication, or risk factors for polymorphic ventricular tachycardia
- •Uncontrolled hypertension
- •Left ventricular ejection fraction (LVEF) <40%, as determined by screening echocardiogram (echocardiogram results obtained within 90 days prior to screening are acceptable)
- •QT/QTc interval >450 msec, as determined by screening electrocardiogram (ECG)
- •Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ≤ 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.
- •Major surgery within 4 weeks prior to IP administration
- •Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
- •Active infection requiring IV antibiotics within 2 weeks prior to screening
- •Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease.
- •Participant has received a live vaccine within 4 weeks prior to screening
- •Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
- •Participant has been exposed to an investigational product (IP) or investigational device in another clinical study within 4 weeks prior to IP administration, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- •Participant is nursing or intends to begin nursing during the course of the study
- •Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s), that in medical judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study
- •Participant is a family member or employee of the investigator
结局指标
主要结局
Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
时间窗: 14 months
次要结局
- Number of participants experiencing dose limiting toxicity (DLT)(14 months)
- Plasma pharmacokinetic parameters(28 days)
- Number of participants experiencing related serious adverse events (SAEs) and/or adverse events (AEs)(14 months)
- Levels of free active MIF and free total MIF in plasma and tumor tissue (where applicable)(14 months)
- Number of serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality(14 Months)
- Number of participants who develop binding and/or neutralizing anti-anti-macrophage migration inhibitory factor (anti-MIF) antibodies following treatment with anti-MIF(14 months)
- Tumor response(14 months)
- Change in levels of tumor-associated biomarkers, if applicable based on cancer type, following treatment with anti-MIF antibody(14 months)
- Number of related serious adverse events (SAEs) and/or adverse events (AEs)(14 months)
- Number of dose limiting toxicities (DLTs)(14 months)
- Anti-MIF antibody in tumor tissues, bound and/or unbound to active MIF (where applicable)(14 Months)
- Levels of other potential biomarkers in tumor tissue (where applicable)(14 Months)
研究者
研究点 (10)
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