A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Morphotek
- 入组人数
- 154
- 试验地点
- 65
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.
详细描述
Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females >18 years old
- •Diagnosis of metastatic, colorectal cancer
- •Significant medical conditions must be well-controlled and stable for at least 30 days prior to the first treatment infusion
- •Be willing and able to provide written informed consent
排除标准
- •No prior treatment for metastatic colorectal cancer
- •Other serious systemic diseases (bacterial or fungal)
- •Clinically significant heart disease or an arrhythmia on an ECG within the past 6 months
- •Known allergic reaction to monoclonal antibody therapy
研究组 & 干预措施
MORAb-004
干预措施: MORAb-004 (Drug)
MORAb-004
干预措施: Best supportive care (Other)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Best supportive care (Other)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves.
次要结局
- Overall Survival (OS)(From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months))
- Biomarkers Based OS, Within Treatment Group(From the date of randomization up to approximately 1 year 7 months)
- Overall Response Rate (ORR)(From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months))
- Time to Tumor Response (TTR)(From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months))
- Duration of Response (DOR)(From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months))
- Biomarkers Based PFS, Within Treatment Group(From the date of randomization up to approximately 1 year 7 months)