NL-OMON47883已完成不适用
A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors - Phase I study on VEGF vaccination in metastatic solid tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically confirmed advanced, solid malignancy.
- •2. Refractory or not amenable to standard therapy
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •4. Willing and able to give written informed consent
- •5. Patient is * 18 years of age at the time of signature of the informed consent
- •6. Adequate hematological function: Absolute neutrophil count (ANC) * 1.5 x 109/L, platelets * 100 x 109/L, Hemoglobin * 6.0 mmol/L.
- •7. Adequate hepatic function: serum bilirubin * 1.5 times the upper limit of normal (ULN), ALT and AST * 2.5 x ULN (or * 5 times ULN if liver metastases are present).
- •8. Adequate renal function: eGFR * 50ml/min
- •9. PT-INR/PTT < 1.5 x ULN, unless coumarin derivatives are used
- •10. Activated partial thromboplastin time (APTT) < 1.25 x ULN (therapeutic anticoagulation therapy is allowed, if this treatment can be interrupted for a biopsy as judged by the treating physician)
- •11. Female patients of childbearing potential may be enrolled in the study, if the patient
- •- Has practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration.
- •- Negative pregnancy test
- •- Has agreed to continue adequate contraception for as long as VEGF is neutralized.
排除标准
- •1. Major surgery within 28 days before the initiation of study treatment
- •2. Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
- •3. Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
- •4. Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
- •5. The patient is scheduled to receive another vaccination during the DLT period.
- •6. A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
- •7. Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
- •8. Uncontrolled auto-immune diseases
- •9. Primary or secondary immunodeficiency, including HIV
- •10. Treatment with a glucocorticoid derivative in an equivalent dose of * 10mg prednisone a day.
- •11. Female patients: the patient is pregnant or lactating.
- •12. When the patient is scheduled to receive any other anticancer treatments.
- •13. Chemotherapy within 28 days prior to the initiation of study treatment.
研究者
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