Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Study Overview
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Brief Summary
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Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.

Official Title
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A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer

Conditions
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Skin Neoplasms

Intervention / Treatment
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* Drug: BLZ-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients age ≥ 18 years. Known or suspected non-metastatic basal cell or squamous cell carcinomas ≥10 mm longest diameter or non-metastatic melanoma ≥6 mm longest diameter scheduled for excision, without advanced disease. Written Informed Consent. Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential. Available for and able to comply with study requirements. Exclusion Criteria: Women who are lactating/breastfeeding Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study. Life expectancy <6 months. Karnofsky Performance Status of ≤70%. The following laboratory abnormalities: Neutrophil count <1.5 x 10^9/L Platelets <75 x 10^9/L Haemoglobin <10 g/dL (may be determined following transfusion) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN) Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction) International Normalized Ratio (INR) >1.5 Creatinine >1.5x ULN History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization. Uncontrolled asthma or asthma requiring oral corticosteroids. Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator. Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening. Uncontrolled hypertension. QTc (corrected QT interval) prolongation >450 msec. Receipt of photosensitising drugs within 30 days of screening. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). 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. Known or suspected sensitivity to study product or excipients. Prior participation in this clinical trial (has received study product).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLZ-100<br>A single dose of BLZ-100 (1, 3, 6, 12 or 18 mg) will be administered by intravenous injection approximately 48 hours prior to planned excision of skin tumor. | Drug: BLZ-100<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. | Within at least 1 week from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of BLZ-100 in the blood | BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters. | Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Determination of a dose level for Phase 2 studies |  | At end of study - approximately 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin cancer, Basal cell carcinoma, Squamous cell carcinoma, Melanoma