NCT02031731已完成1 期
A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.
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
- •Age >/= 18 years
- •Histologically confirmed locally advanced or metastatic solid tumor that does not respond to standard treatment or for which there is no further standard treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status from 0 to
- •Use of effective contraception
- •Life expectancy > 3 months
排除标准
- •Brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation, and/or patients with brain metastasis that have been receiving corticosteroids.
- •Previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression that has not been clinically stable for at least 2 months.
- •Treatment with anti-tumor therapy within 4 weeks before the start of study treatment, with the following exception: Patients with metastatic prostate cancer on maintenance hormonal therapy, provided they meet all other eligibility criteria.
- •Current, serious or uncontrolled, systemic illness.
- •Recent stroke (within the past 6 months).
- •Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs).
- •History of cardiovascular conditions.
- •Any other disease, gastrointestinal abnormality, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- •Receipt of any investigational agent, or participation in any other clinical study, within 4 weeks before the start of study treatment.
- •Major surgery within 4 weeks before the start of study treatment, without complete recovery.
- •Significant traumatic injury within 3 weeks before the start of study treatment (All wounds must be fully healed prior to Day 1).
- •Uncontrolled excess calcium levels.
- •Known human immunodeficiency virus (HIV) infection.
- •Inadequate organ function
- •Pregnancy
研究组 & 干预措施
4 mg/kg Onartuzumab (MetMAb)
Experimental
干预措施: 4 mg/kg Onartuzumab (MetMAb) (Drug)
15 mg/kg Onartuzumab (MetMAb)
Experimental
干预措施: 15 mg/kg Onartuzumab (MetMAb) (Drug)
30 mg/kg Onartuzumab (MetMAb)
Experimental
干预措施: 30 mg/kg Onartuzumab (MetMAb) (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 1 year
Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)
时间窗: Up to 1 year
次要结局
- Incidence of anti-therapeutic antibodies against MetMAb(Up to 1 year)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in ChinaHealthy VolunteersNCT05268068AbbVie30
撤回
1 期
Pharmacokinetics of Single and Repeat Oral Doses of Trametinib in Chinese Subjects With Solid TumoursCancerNCT02939846GlaxoSmithKline
撤回
1 期
Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With MelanomaMelanomaNCT02447939GlaxoSmithKline
Unknown
1 期
Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy SubjectsT2DM (Type 2 Diabetes Mellitus)NCT05369078Newsoara Biopharma Co., Ltd.16
已完成
1 期
Phase I, Study in Chinese NSCLC PatientsCarcinoma, Non-Small-Cell Lung With EGFR Mutation PositiveNCT02529995AstraZeneca31