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Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Primary Purpose

Skin Neoplasms

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BLZ-100
Sponsored by
Blaze Bioscience Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Neoplasms focused on measuring Skin cancer, Basal cell carcinoma, Squamous cell carcinoma, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Veracity Clinical Research Pty Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BLZ-100

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with adverse events
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.

Secondary Outcome Measures

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.
Determination of a dose level for Phase 2 studies

Full Information

First Posted
March 25, 2014
Last Updated
April 20, 2015
Sponsor
Blaze Bioscience Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02097875
Brief Title
Safety Study of a Fluorescent Marker to Visualize Cancer Cells
Official Title
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blaze Bioscience Australia Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms
Keywords
Skin cancer, Basal cell carcinoma, Squamous cell carcinoma, Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLZ-100
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BLZ-100
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Time Frame
Within at least 1 week from baseline
Secondary Outcome Measure Information:
Title
Change in concentration of BLZ-100 in the blood
Description
BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
Time Frame
Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Title
Determination of a dose level for Phase 2 studies
Time Frame
At end of study - approximately 14 months
Other Pre-specified Outcome Measures:
Title
Change in fluorescence signal in urine
Description
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.
Time Frame
Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose
Title
Change in fluorescent signal in skin tumor and normal skin
Description
Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system.
Time Frame
Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose
Title
Expression of biomarkers of response in excised skin tumor
Description
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.
Time Frame
48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Spelman, MBBS FACD
Organizational Affiliation
Veracity Clinical Research Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
34401600
Citation
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.
Results Reference
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Safety Study of a Fluorescent Marker to Visualize Cancer Cells

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