None listed
Conditions
Brief summary
This study is evaluating the safety of a fluorescent marker (BLZ-100) used to visualise cancer cells in adults with skin cancer. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with non-melanotic skin cancer (e.g. non metastatic basal cell or squamous cell carcinomas or amelanotic melanoma) and are scheduled for surgical excision. Many types of cancer are primarily treated with surgery and the extent of surgical removal of the tumour is directly related to patient survival. However, it is often difficult for surgeons to distinguish tumour tissue from normal tissue or to detect tumour cells that have spread from the original tumour site. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumour to prevent adverse effects on function. In this study all participants will be administered BLZ-100 intravenously (i.e. directly into the vein) approximately 48 hours before scheduled excision of cancer lesions. BLZ-100 is a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer cells to facilitate surgical resection. We hope that BLZ-100 will improve surgical outcomes by allowing surgeons to visualise the edges of the tumour and small groups of cancer cells in real-time, as they operate.
Interventions
BLZ-100, a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer foci to facilitate surgical resection. BLZ-100 will be administered as a single, intravenous dose approximately 48 hours before scheduled excision of skin cancer lesions. The study consists of two parts: a dose escalation and a dose expansion. In the dose escalation part of the study, the dose of BLZ-100 will be increased in cohorts of subjec
BLZ-100, a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer foci to facilitate surgical resection. BLZ-100 will be administered as a single, intravenous dose approximately 48 hours before scheduled excision of skin cancer lesions. The study consists of two parts: a dose escalation and a dose expansion. In the dose escalation part of the study, the dose of BLZ-100 will be increased in cohorts of subjects until either the highest pre-specified dose level is reached or unacceptable side effects are noted. The planned dose cohorts are 1, 3, 6, 12 and 18 mg BLZ-100. Escalation to a higher dose cohort will proceed when the previous dose has been found to be reasonably tolerated based on available safety data for all subjects enrolled in the cohort. Upon completion of the dose escalation, a dose level shown to be well-tolerated will be selected to enrol subjects in the dose expansion part of the study.
Sponsors
Blaze Bioscience Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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).
Outcome results
None listed