Clinical trial NCT05316688: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Blaze Bioscience Inc.
First posted: 2022-04-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 7-21 days after drug administration
Secondary outcomes:
measure: Number of subjects without tumor fluorescence after receiving tozuleristide
timeFrame: Up to 12 months
measure: Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies
timeFrame: Up to 12 months
measure: Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies
timeFrame: Up to 12 months
measure: Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies
timeFrame: Up to 12 months
measure: Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies
timeFrame: Up to 12 months
measure: Achievement of negative margins in tozuleristide-guided oral cavity tumor excision
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Emily Marchiano
role: PRINCIPAL_INVESTIGATOR
References: