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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12614000115639 | Registry Identifier | ANZCTR |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLZ-100 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLZ-100 | Drug |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fluorescence signal in urine | Fluorescence signal in urine samples will be measured using an infrared imaging system to determine the amount of BLZ-100 being excreted in the urine post-dosing. | Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose |
| Change in fluorescent signal in skin tumor and normal skin |
Inclusion Criteria:
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Spelman, MBBS FACD | Veracity Clinical Research Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34401600 | Derived | Yamada M, Miller DM, Lowe M, Rowe C, Wood D, Soyer HP, Byrnes-Blake K, Parrish-Novak J, Ishak L, Olson JM, Brandt G, Griffin P, Spelman L, Prow TW. A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients. Contemp Clin Trials Commun. 2021 Aug 4;23:100830. doi: 10.1016/j.conctc.2021.100830. eCollection 2021 Sep. |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000604732 | tozuleristide |
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| At end of study - approximately 14 months |
Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system. |
| Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose |
| Expression of biomarkers of response in excised skin tumor | Immunohistochemistry will be used to measure the expression of other biomarkers of response, including Annexin A2, Ki67 and MMP2 (matrix metalloproteinase-2), in normal and tumor tissue. | 48 hours post-dose |
| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |