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

Phase 1

Recruiting

• Conditions: Stage III Lip and Oral Cavity Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Oral Cavity Squamous Cell Carcinoma; Stage I Lip and Oral Cavity Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8
• Interventions: Procedure: Near Infrared Imaging; Procedure: Therapeutic Conventional Surgery; Drug: Tozuleristide

• Registration Number: NCT05316688
• Lead Sponsor: University of Washington

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2024-04-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-01-20
• Study Completion: 2027-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (tozuleristide, surgery, NIR imaging)	Near Infrared 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.
Diagnostic (tozuleristide, surgery, NIR imaging)	Therapeutic Conventional Surgery	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.
Diagnostic (tozuleristide, surgery, NIR imaging)	Tozuleristide	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	7-21 days after drug administration	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.

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies	Up to 12 months
Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies	Up to 12 months	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.
Number of subjects without tumor fluorescence after receiving tozuleristide	Up to 12 months
Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies	Up to 12 months	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.
Achievement of negative margins in tozuleristide-guided oral cavity tumor excision	Up to 12 months	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.
Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies	Up to 12 months

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States