ACTRN12614000115639已完成1 期
A Phase 1 dose escalation/expansion study of BLZ-100 administered by intravenous injection in adult subjects with skin cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
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 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patients age 18 years or older.
- •2. Known or suspected non-metastatic basal cell or squamous cell carcinomas equal to or greater than 10 mm longest diameter or non-metastatic melanoma equal to or greater than 6 mm longest diameter scheduled for excision, without advanced disease.
- •3. Written Informed Consent.
- •4. Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
- •5. Available for and able to comply with study requirements.
排除标准
- •1. Women who are lactating/breastfeeding
- •2. Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
- •3. Life expectancy <6 months.
- •4. Karnofsky Performance Status of 70% or less.
- •5. The following laboratory abnormalities:
- •a) Neutrophil count <1.5 x 109/L
- •b) Platelets <75 x 109/L
- •c) Haemoglobin <10 g/dL (may be determined following transfusion)
- •d)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)
- •e) Total bilirubin >2x upper limit of reference range (unless Gilbert’s syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- •f) International Normalized Ratio (INR) >1.5
- •g) Creatinine >1.5x ULN
- •6. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
- •7. Uncontrolled asthma or asthma requiring oral corticosteroids.
- •8. Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
- •9. Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
- •10. Uncontrolled hypertension.
- •11. QTc prolongation >450 msec.
- •12. Receipt of photosensitising drugs within 30 days of screening.
- •13. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
- •14. Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
- •15. Known or suspected sensitivity to study product or excipients.
- •16. Prior participation in this clinical trial (has received study product).
研究者
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