NCT01847118Unknown1 期
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
- •Patients failed the standard anti-tumor therapy or don't have standard regimen;
- •At least one measurable lesion;
- •At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
- •Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
- •ECOG performance status 0-1;
- •Life expectancy ≥ 3 months;
- •Adequate hematologic function: ANC ≥ 1.5 × 10^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10^9 /L;
- •Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);
- •Adequate renal function: creatinine ≤ 1 × ULN;
- •Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
- •Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.
排除标准
- •HCV, TP or HIV antibody positive;
- •Previously received anti-VEGF protein drugs, such as bevacizumab;
- •Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
- •Active hepatitis B infection;
- •Evidence of serious infection;
- •Symptomatic brain metastases;
- •Patients with proteinuria at screening (urine protein ≥ 1+);
- •History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
- •Serious non-healing wounds, ulcers or fractures;
- •Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;
- •Active bleeding within 3 months prior to enrollment;
- •Bleeding diathesis or coagulation disorder;
- •History of arterial or venous thrombosis;
- •History of myocardial infarction or stroke within 6 months prior to enrollment;
- •Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mmHg);
- •Pregnant and lactating women;
- •Known allergies to any excipient in the study drug;
- •Patients with alcohol or drug dependence;
- •Participation in other clinical trials within 4 weeks before enrollment.
研究组 & 干预措施
Sevacizumab
Experimental
2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57
干预措施: Sevacizumab (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: up to 28 days
次要结局
- Cmax(d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57)
- tmax(d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57)
- AUC(d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57)
- t1/2(d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57)
- Objective Response Rate (ORR)(d29, d86)
- Disease Control Rate (DCR)(d29, d86)
研究者
研究点 (1)
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