ACTRN12617000037303进行中（未招募）1 期
A Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (EGFR(V)-EDV-PNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDV-60mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
- •2.Life expectancy greater than 3 months
- •3.Histologically or cytologically confirmed advanced solid tumour that is metastatic or unresectable and for which standard curative or palliative measures are not available or are no longer effective.
- •4.Measurable disease per iRECIST criteria.
- •5.Able to undergo CT or MRI (+/- PET) evaluation as applicable to tumour type.
- •6. Available archived primary or metastatic neoplastic tumour tissue available for EGFR expression staining, if not already performed as standard of care.
- •6..Adequate cardiac function with LVEF greater or equal to 50% at baseline.
排除标准
- •1.Significant pericardial effusions, pleural effusions or ascites.
- •2.Concurrent unstable diabetes mellitus or other contraindications for the use of dexamethasone.
- •3.Uncontrolled concurrent cardiac disease including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- •4.Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis.
- •5.History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled on low dose molecular weight heparins or low dose aspirin.
- •6.Uncontrolled brain metastases. Subjects with a history of brain metastases are eligible if the subject is stable and off corticosteroids for at least 2 weeks prior to treatment in the study. PAtients who have undergone glucocorticoid tapering but who have not tolerated complete withdrawal and still require a nominal maintenance dose, will be reviewed on a case by case basis.
- •7. Active or uncontrolled severe infection.
- •8. Previous or current primary malignancies at other sites within last 2 years, except:
- •- In situ carcinoma of the cervix
- •- Adequately treated basal cell or squamous cell carcinoma of the skin.
- •9.Received therapies or procedures within 28 days prior to Cycle 1, Dose 1 (or has not recovered from the toxic effects of such therapy) including:
- •-Therapy with an EGFR inhibitor e.g. cetuximab or erlotinib
- •-Anti-angiogenic therapy e.g. Bevacizumab (Avastin)
- •-Immunotherapeutic agents, vaccines, or monoclonal antibody therapy
- •-Alkylating agents
- •-Chemotherapy
- •- Radiotherapy with the exception of palliative radiotherapy
- •-Other investigational therapy.
- •-Any major surgery.
- •10.Prior exposure to PNU.
研究者
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