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

Primary Purpose

Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Near Infrared Imaging

Therapeutic Conventional Surgery

Tozuleristide

About this trial

This is an interventional diagnostic trial for Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (tozuleristide, surgery, NIR imaging)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of subjects without tumor fluorescence after receiving tozuleristide

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.

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.

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

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

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.

Full Information

NCT ID

NCT05316688

First Posted

March 17, 2022

Last Updated

October 12, 2023

Sponsor

University of Washington

Collaborators

Blaze Bioscience Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05316688

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 12, 2023 (Anticipated)

Primary Completion Date

January 20, 2026 (Anticipated)

Study Completion Date

January 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Washington

Collaborators

Blaze Bioscience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (tozuleristide, surgery, NIR imaging)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Near Infrared Imaging

Other Intervention Name(s)

Near-Infrared Imaging, NIR Imaging

Intervention Description

Undergo NIR imaging

Intervention Type

Procedure

Intervention Name(s)

Therapeutic Conventional Surgery

Intervention Description

Undergo surgery

Intervention Type

Drug

Intervention Name(s)

Tozuleristide

Other Intervention Name(s)

BLZ-100

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Description

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.

Time Frame

7-21 days after drug administration

Secondary Outcome Measure Information:

Title

Number of subjects without tumor fluorescence after receiving tozuleristide

Time Frame

Up to 12 months

Title

Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies

Description

Time Frame

Up to 12 months

Title

Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies

Description

Time Frame

Up to 12 months

Title

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

Time Frame

Up to 12 months

Title

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

Time Frame

Up to 12 months

Title

Achievement of negative margins in tozuleristide-guided oral cavity tumor excision

Description

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.

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Wood

Phone

206-606-6970

Rwood1@seattlecca.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily Marchiano

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Wood

Phone

206-606-6970

Rwood1@seattlecca.org

First Name & Middle Initial & Last Name & Degree

Emily Marchiano

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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