Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery

Exclusion Criteria

• •1. Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor \[PNET\])
• •2. Evidence of metastatic disease
• •3. Female who is lactating/breastfeeding
• •4. Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study
• •5. Karnofsky Performance Status of \<60%
• •6. Any of the following laboratory abnormalities at Screening:
• •* Neutrophil count \<1.5 x 10\^9/L
• •* Platelets \<75 x 10\^9/L
• •* Hemoglobin \<10 g/dL (may be determined following transfusion)
• •* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
• •* Total bilirubin \>1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
• •* Internal Normalized Ratio (INR) \>1.5
• •* Creatinine \>1.5x ULN
• •* Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min
• •7. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
• •8. QTc prolongation \>450 msec
• •9. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization
• •10. Uncontrolled asthma or asthma requiring oral corticosteroids
• •11. Known or suspected sensitivity to imaging agents that may be used in clinical assessment of this study
• •12. Known or suspected sensitivity to indocyanine green (ICG)
• •13. Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening
• •14. Uncontrolled hypertension
• •15. Initiation of new photosensitizing drugs within 30 days of Screening
• •16. Use of any ongoing medications, which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix
• •17. Receipt of an investigational drug or device within 30 days of enrollment
• •18. Prior administration of BLZ-100
• •19. Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data