NCT01514123已完成1 期
A Phase I, Open Label, Dose Escalation Study of the VEGF-C Human Monoclonal Antibody VGX-100 Administered by Intravenous Infusion Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced or Metastatic Solid Tumors
Circadian Technologies Ltd.2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年12月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- The incidence and severity of adverse events including dose limiting toxicities
研究概览
简要总结
This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100 alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100 when administered alone or in combination with bevacizumab.
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
- •Provision of written informed consent
- •Histologically or cytologically documented advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy
- •Life expectancy > 3 months in the opinion of the investigator
- •ECOG performance status 0 to 1
- •Evaluable OR measurable disease by RECIST 1.1 criteria
- •Agree to the use of effective contraceptive if either male or female of child bearing potential
排除标准
- •Inadequate venous access
- •Women who are lactating/breastfeeding
- •Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study
- •Known to be HIV positive, or have chronic hepatitis B or C
- •Major surgical procedure within 6 weeks of Baseline or surgical or other wound that is not fully healed at Baseline
- •Untreated or symptomatic brain metastasis, known central nervous system metastasis, or spinal cord compression (except glioblastoma multiforme)
- •Mediastinal or cavitated, or lung mass located near, invading or encasing a major blood vessel or airway on imaging
- •Squamous cell lung cancer
- •History of or known/suspected gastrointestinal perforation
- •Hemoptysis of >2.5 mL (half a teaspoon) red blood within 28 days of Screening
- •Deep venous thrombosis or history of symptomatic pulmonary thromboembolism within 6 months of Screening
- •Gastrointestinal bleeding requiring medical intervention within 28 days of Screening
- •Receipt of therapeutic concentrations of warfarin or other anticoagulants within 7 days of Screening
- •Receipt of investigational agent(s) for any indication within 28 days of Baseline or 5 half lives, whichever is greater
- •Receipt of the following treatments:
- •Traditional cytotoxics, tyrosine kinase inhibitors or other small molecule anti-cancer agents within 21 days
- •Nitrosoureas, mitomycin C, bevacizumab or trastuzumab within 6 weeks
- •Any other therapeutic monoclonal antibodies within 21 days
- •Hormonal therapy (other than gonadal suppression) within 14 days
- •Radiotherapy:
- •to >25% bone marrow
- •to brain within 28 days of baseline
- •other than above within 14 days of baseline
- •Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of Screening
- •History of CNS hemorrhage, cerebrovascular hemorrhage, myocardial infarction or reversible posterior leukoencephalopathy syndrome associated with prior anti-VEGF/anti-VEGFR therapy
- •Uncontrolled hypertension of ≥ CTCAE Grade 2
- •Proteinuria at Baseline of ≥2+ or 1.0g/24 hours
- •Prior allergic reaction to a monoclonal antibody
研究组 & 干预措施
Arm A - VGX-100 alone
Experimental
Dose escalation of VGX-100 monotherapy
干预措施: VGX-100 (Drug)
Arm B - VGX-100 plus bevacizumab
Experimental
Dose escalation of VGX-100 in combination with escalating doses of bevacizumab
干预措施: VGX-100 (Drug)
Arm B - VGX-100 plus bevacizumab
Experimental
Dose escalation of VGX-100 in combination with escalating doses of bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
The incidence and severity of adverse events including dose limiting toxicities
时间窗: Approximately 16 months
次要结局
- Anti-VGX-100 antibody formation(Approximately 16 months)
- Pharmacokinetic parameters of VGX-100 alone and co-administered with bevacizumab including Cmax, Cmin, AUC and if feasible half life (t1/2)(28 days after the last subject in each cohort)
- Tumor response by RECIST criteria(Approximately 16 months)
- Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3(Approximately 16 months)
研究者
研究点 (2)
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