ACTRN12619000385145终止1 期
A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying an immunomodulator (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 53
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 No limit（—）
- 性别
- All
入选标准
- •1. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
- •2. Life expectancy greater than or equal to 3 months
- •3.Histologically or cytologically confirmed pancreatic cancer or other solid tumours known to express EGFR including, but not limited to, kidney cancer (renal cell adenocarcinoma), melanoma, bladder cancer, colorectal cancer, non-small cell lung cancer (NSCLC) and head and neck cancer.
- •4.Measurable disease per iRECIST criteria.
- •5.Must be able to undergo CT or MRI (+/- PET) evaluation.
- •6.Available archived primary or metastatic neoplastic tumour tissue available for EGFR expression staining.
- •7.Adequate haematological function.
- •8.Adequate renal function
- •9.Adequate hepatic function
- •11.Adequate cardiac function with LVEF greater than or equal to 50% at baseline.
- •12.Serum phosphate levels within normal range (2.1-4.1 mg/dL) at baseline.
- •13.Cortisol levels within normal range, in accordance with hospital accredited laboratory reference range.
排除标准
- •1.Significant pericardial effusions, pleural effusions or ascites.
- •2.Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids.
- •3.Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy.
- •4.Clinically significant electrocardiogram (ECG) changes at enrolment which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
- •5.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.
- •6.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.
- •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 the following procedures within 28 days prior to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:
- •-other investigational therapy
- •-radiotherapy
- •-any major surgery.
- •10.Prior other therapies or procedures prior to receiving their first dose:
- •-Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin.
- •-QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes.
- •11.Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
- •12.Female who is pregnant or breastfeeding.
- •13.Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge.
研究者
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