A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

• Status: Not yet recruiting
• Trial end date: 2027-01-20
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Blaze Bioscience Inc.

Criteria

Inclusion Criteria:

• Adult patients age >= 18 years (yr)

• Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery

• Able to provide written informed consent

• If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential

• Available for all study visits and able to comply with all study requirements

Exclusion Criteria:

• Known or suspected sensitivity to indocyanine green

• In the opinion of the treating physician, patient has received photosensitizing medication that could interfere or confound study results

• Any current medications with the potential to generate fluorescence or photochemical reaction

• Enrolled in any other ongoing study

• Currently lactating or breastfeeding

• Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide

• Any current 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

• Creatinine clearance < 60 mL/min

• Aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN)

• Alanine aminotransferase (ALT) > 1.5 x ULN

• Bilirubin > 1.5 x ULN