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

August 21, 2026 updated by: Emily Marchiano, University of Washington

Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult subjects 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, subject 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (tozuleristide, surgery, NIR imaging)
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Procedure: Near Infrared Imaging
Undergo NIR imaging
Other Names:
  • Near-Infrared Imaging
  • NIR Imaging
Drug: Tozuleristide
Given IV
Other Names:
  • BLZ-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs)
Time Frame: 7-21 days after drug administration
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
7-21 days after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide
Time Frame: Measured at time of surgery 1 to 30 hours after receiving tozuleristide
Number of subjects whose tumors did not show discernible fluorescence compared to background
Measured at time of surgery 1 to 30 hours after receiving tozuleristide
Number of Participants for Which Negative Margins Were Achieved in Tozuleristide-guided Oral Cavity Tumor Excision
Time Frame: Surgery performed following tozuleristide injection 1-30 hours prior to surgery
To investigate the accuracy of tozuleristide fluorescent imaging in identifying tumor and achieving negative margins during excision of oral cavity squamous cell carcinoma and high-grade dysplasia.
Surgery performed following tozuleristide injection 1-30 hours prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Blaze Bioscience Inc.

Investigators

  • Principal Investigator: Emily Marchiano, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2024

Primary Completion (Actual)

September 9, 2025

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1122110
  • NCI-2022-01734 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • FHIRB0020096 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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