NCT00352131已完成1 期
A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer, pancreatic cancer, or other solid tumors.
Secondary
- Determine the qualitative and quantitative toxicities of this drug in these patients.
- Characterize the pharmacokinetics of this drug in these patients.
- Describe any antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity
时间窗: for the duration of the trial
Maximum tolerated dose
时间窗: for the duration of the trial
次要结局
- Antitumor activity(for the duration of the trial)
- Toxicity(for the duration of the trial)
- Pharmacokinetics(for the duration of the trial)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult ParticipantsHIV InfectionsNCT03735849National Institute of Allergy and Infectious Diseases (NIAID)28
已完成
1 期
A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple MyelomaMultiple MyelomaNCT01025206BioInvent International AB35
撤回
2 期
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19COVID-19NCT04770467Brii Biosciences, Inc.
已完成
1 期
AMG 404 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT03853109Amgen171
已完成
2 期
CP-675,206 In Patients With Advanced MelanomaMalignant MelanomaNCT00086489AstraZeneca118