Oral Cavity Squamous Cell CarcinomaPhase 1/2NCT05316688

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

A Phase 1/2 study testing Near Infrared Imaging, Therapeutic Conventional Surgery and Tozuleristide in people with Oral Cavity Squamous Cell Carcinoma and Stage I Lip and Oral Cavity Cancer AJCC v8, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8
What is being tested?: Near Infrared Imaging, Therapeutic Conventional Surgery and Tozuleristide
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2024to 26 Sep 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

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
Being tested: Near Infrared Imaging, Therapeutic Conventional Surgery, Tozuleristide
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Near Infrared ImagingProcedure or surgery
Also called Near-Infrared Imaging, NIR Imaging
Undergo NIR imaging
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
TozuleristideDrug
Also called BLZ-100
Given IV

Study groups in NCT05316688
Study group	Role	What they receive
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. Receives: Procedure: Near Infrared Imaging; Procedure: Therapeutic Conventional Surgery; Drug: Tozuleristide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Events (AEs)
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
Measured: 7-21 days after drug administration

Secondary outcomes (2)

Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide
Number of subjects whose tumors did not show discernible fluorescence compared to background
Measured: Measured at time of surgery 1 to 30 hours after receiving tozuleristide
Number of Participants for Which Negative Margins Were Achieved 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.
Measured: Surgery performed following tozuleristide injection 1-30 hours prior to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 202426 Sep 2025

First posted7 Apr 2022
Study start17 Apr 2024
Primary completion9 Sep 2025
Study completion26 Sep 2025

Why it stopped: Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05316688
Sponsor's protocol ID: RG1122110
Other IDs: NCI-2022-01734, FHIRB0020096
Status last verified: Aug 2026
First submitted: 17 Mar 2022
Last updated: 16 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

All Oral Cavity Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent
ClinicalTrials.gov ID: NCT05316688
Acronym / sponsor ID: RG1122110
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa.
Enrolment: 8 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Blaze Bioscience Inc.
Study start: 17 Apr 2024 (actual)
Primary completion: 9 Sep 2025 (actual)
Study completion: 26 Sep 2025 (actual)
First posted: 7 Apr 2022 (actual)
Results: Posted 16 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OUTLINE:

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (tozuleristide, surgery, NIR imaging)	Experimental	Procedure: Near Infrared Imaging, Procedure: Therapeutic Conventional Surgery, Drug: TozuleristideBeginning 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Near Infrared ImagingAlso: Near-Infrared Imaging, NIR ImagingUndergo NIR imaging	Procedure or surgery	Diagnostic (tozuleristide, surgery, NIR imaging)
Therapeutic Conventional SurgeryUndergo surgery	Procedure or surgery	Diagnostic (tozuleristide, surgery, NIR imaging)
TozuleristideAlso: BLZ-100Given IV	Drug	Diagnostic (tozuleristide, surgery, NIR imaging)

Primary outcome

Number of Adverse Events (AEs)
Time frame: 7-21 days after drug administration
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.

2 secondary outcomes

Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide
Time frame: Measured at time of surgery 1 to 30 hours after receiving tozuleristide
Number of Participants for Which Negative Margins Were Achieved in Tozuleristide-guided Oral Cavity Tumor Excision
Time frame: Surgery performed following tozuleristide injection 1-30 hours prior to surgery

Results and safety

Results posted to the registry on 16 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Tozuleristide, Surgery, NIR Imaging)	8	8

Primary outcome: Number of Adverse Events (AEs)

Time frame: 7-21 days after drug administration. Number. Unit: Event

Measure	Diagnostic (Tozuleristide, Surgery, NIR Imaging) n = 8
Acute hypoxemia, grade 3	1
Aspiration pneumonia, grade 3	1
Back wound, grade 3	1
Constipation, grade 2	1
Covid-19 infection, grade 3	1
Fatigue, grade 3	2
Ileus, grade 3	1
Neck infection, grade 2	1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time from administration of tozuleristide through the first postoperative follow-up visit occurring 7-21 days after study drug administration (End of Study Visit). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Tozuleristide, Surgery, NIR Imaging)	2 of 8 (25%)	3 of 8 (37.5%)	0 of 8

Limitations and caveats (from the sponsor): This study was terminated early due to lack of consistent tozuleristide fluorescence of oral cavity tumors

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Oral Cavity Squamous Cell Carcinoma

RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Marchiano principal investigator

Fred Hutch/University of Washington Cancer Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (AEs) (time frame: 7-21 days after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.