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

NCT05316688 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: RG1122110NCI-2022-01734FHIRB0020096
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Cavity Squamous Cell Carcinoma; Stage I Lip and Oral Cavity Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.

  7-21 days after drug administration

Secondary Outcomes (6)

• Number of subjects without tumor fluorescence after receiving tozuleristide

  Up to 12 months

• Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies

  Up to 12 months

• Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies

  Up to 12 months

• Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies

  Up to 12 months

• Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies

  Up to 12 months

Study Arms (1)

Diagnostic (tozuleristide, surgery, NIR imaging)

EXPERIMENTAL

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: Near Infrared Imaging; Procedure: Therapeutic Conventional Surgery; Drug: Tozuleristide

Interventions

Tozuleristide DRUG

Given IV

Also known as: BLZ-100

Diagnostic (tozuleristide, surgery, NIR imaging)

Near Infrared Imaging PROCEDURE

Undergo NIR imaging

Also known as: Near-Infrared Imaging, NIR Imaging

Diagnostic (tozuleristide, surgery, NIR imaging)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Diagnostic (tozuleristide, surgery, NIR imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Blaze Bioscience Inc.: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Emily Marchiano

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 7, 2022
• Study Start: April 17, 2024
• Primary Completion: September 9, 2025
• Study Completion: September 26, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)