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

Oral Cavity Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316688
• Other study ID #: RG1122110
• Secondary ID: NCI-2022-01734FH
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 17, 2024
• Est. completion date: January 20, 2027

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Emily Marchiano
• Phone: 206-598-5000
• Email: ejm1014[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 20, 2027
• Est. primary completion date: January 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cavity Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• 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

Intervention

Procedure:
• Near Infrared Imaging
Undergo NIR imaging
• Therapeutic Conventional Surgery
Undergo surgery

Drug:
• Tozuleristide
Given IV

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Blaze Bioscience Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects without tumor fluorescence after receiving tozuleristide		Up to 12 months
Secondary	Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies	Will be estimated by a repeated measure logistic regression modeling the probability of positive tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A general estimating equation (GEE) method will be used to estimate the regression parameters.	Up to 12 months
Secondary	Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies	Will be estimated by a repeated measure logistic regression modeling the probability of negative tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A GEE method will be used to estimate the regression parameters. The repeated measures logistic regression will model the probability of tumor-negative biopsies.	Up to 12 months
Secondary	Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies		Up to 12 months
Secondary	Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies		Up to 12 months
Secondary	Achievement of negative margins in tozuleristide-guided oral cavity tumor excision	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.	Up to 12 months