SCC - Squamous Cell CarcinomaPhase 1NCT07217028
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
A Phase 1 study testing Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030 and Positron Emission Tomography (PET) in people with SCC - Squamous Cell Carcinoma and Radiotracer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of [18F]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030 and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
- Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
- Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):
- Hemoglobin ≥ 9gm/dL
- White blood cell count > 3000/mm3
Show all 11Show fewer
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- Potassium
- Magnesium
- Phosphorus
Who cannot join
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
- Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
- Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
- Participants presenting with a baseline QTcF interval > than 480 milliseconds.
- Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Nicole Jones, 615-936-2807, nicole.l.jones@vumc.org
Makenna Brown, 615-421-4370, makenna.l.brown@vumc.org
About this study
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of [18F]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of [18F]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and [18F]FDG-PET/CT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.
- Conditions
- SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Being tested
- Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030, Positron Emission Tomography (PET)
- Keywords
- unknown primary, cancer, hnscc, scc
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab (EGFR inhibitor)Drug
Given IV
18F-NOTA-ABY-030Drug
Given Bolus Injection
Positron Emission Tomography (PET)Procedure or surgery
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans) | Experimental | Cohort A will include a minimum of six participants up to 12 participants. These participants will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of [18F]NOTA-ABY-030 at a dose of 5 (±1) mCi. To evaluate tracer distribution and radiation exposure, participants in this cohort will undergo three whole-body PET/CT scans at specific timepoints: 0-90 minutes, 120 minutes, and 240 minutes post-injection. Each scan will cover the region from the skull to mid-thigh, with a total imaging time of approximately 90 minutes. This cohort is essential for determining the absorbed dose, organ-specific uptake, identification of critical organs, and the effective dose of the radiopharmaceutical. The data collected from Cohort A will inform safety parameters and support dose optimization for future clinical studies involving [18F]NOTA-ABY-030. Receives: Drug: Cetuximab (EGFR inhibitor); Drug: 18F-NOTA-ABY-030; Procedure: Positron Emission Tomography (PET) |
| Cohort 2 - (1 Whole Body PET/CT Scan) | Experimental | Cohort 2 will include a minimum of thirteen participants. Each participant will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of [18F]NOTA-ABY-030 at a dose of 5 (±1) mCi. Imaging for this cohort will be conducted at a single timepoint, approximately 0-240 minutes (±15 minutes) post-injection, based on optimized timing derived from Cohort 1 data. The PET/CT scan for Cohort 2 will cover the region from skull to chest, with a total scan time of approximately 30 minutes. This cohort is designed to evaluate the diagnostic performance of [18F]NOTA-ABY-030 in identifying indeterminate metastatic and/or primary lesions in head and neck squamous cell carcinoma (HNSCC), with a focus on sensitivity, specificity, and feasibility of the imaging protocol in a broader patient population. Receives: Drug: Cetuximab (EGFR inhibitor); Drug: 18F-NOTA-ABY-030; Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.
As determined by the number of adverse events (AEs) that are possibly or probably related to the study drug within 24 hours after infusion. Dose limiting toxicities will be defined as an AE grade >2 that is clinically significant and attributable to the study drug.
Measured: From infusion to 7 days post-infusion
Secondary outcomes (2)
Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects.
The dosimetry for [18F]NOTA-ABY-030 will be determined to be the absorbed dose, organ specific uptake, critical organs, and effective dose for this first-in-human radiopharmaceutical.
Measured: From infusion to 7 days post-infusion
Compare sensitivity and specificity of standard of care imaging modalities (MRI, CT, and/or [18F]FDG PET/CT) to [18F]NOTA-ABY-030-PET/CT for detection of indeterminate metastatic and/or primary lesion(s) in HNSCC
The specificity and sensitivity of [18F]NOTA-ABY-030 will be compared to the specificity and sensitivity of standard of care imaging obtained (MRI, CT, and/or [18F]FDG PET/CT) for identification of metastatic or primary lesion.
Measured: From infusion to 7 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start24 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCC - Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eben Rosenthal, Vanderbilt University Medical Center
- Investigators
- Eben Rosenthal, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217028
- Sponsor's protocol ID
- VICCHNP25055
- Status last verified
- May 2026
- First submitted
- 13 Oct 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study. Additionally, the data collected may not meet the robustness or generalizability standards required for broader dissemination. The investigators do not plan to share IPD with other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07217028
- Acronym / sponsor ID
- VICCHNP25055
- Conditions
- SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Keywords
- unknown primary, cancer, hnscc, scc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of [18F]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of [18F]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and [18F]FDG-PET/CT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans) | Experimental | Drug: Cetuximab (EGFR inhibitor), Drug: 18F-NOTA-ABY-030, Procedure: Positron Emission Tomography (PET)Cohort A will include a minimum of six participants up to 12 participants. These participants will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of [18F]NOTA-ABY-030 at a dose of 5 (±1) mCi. To evaluate tracer distribution and radiation exposure, participants in this cohort will undergo three whole-body PET/CT scans at specific timepoints: 0-90 minutes, 120 minutes, and 240 minutes post-injection. Each scan will cover the region from the skull to mid-thigh, with a total imaging time of approximately 90 minutes. This cohort is essential for determining the absorbed dose, organ-specific uptake, identification of critical organs, and the effective dose of the radiopharmaceutical. The data collected from Cohort A will inform safety parameters and support dose optimization for future clinical studies involving [18F]NOTA-ABY-030. |
| Cohort 2 - (1 Whole Body PET/CT Scan) | Experimental | Drug: Cetuximab (EGFR inhibitor), Drug: 18F-NOTA-ABY-030, Procedure: Positron Emission Tomography (PET)Cohort 2 will include a minimum of thirteen participants. Each participant will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of [18F]NOTA-ABY-030 at a dose of 5 (±1) mCi. Imaging for this cohort will be conducted at a single timepoint, approximately 0-240 minutes (±15 minutes) post-injection, based on optimized timing derived from Cohort 1 data. The PET/CT scan for Cohort 2 will cover the region from skull to chest, with a total scan time of approximately 30 minutes. This cohort is designed to evaluate the diagnostic performance of [18F]NOTA-ABY-030 in identifying indeterminate metastatic and/or primary lesions in head and neck squamous cell carcinoma (HNSCC), with a focus on sensitivity, specificity, and feasibility of the imaging protocol in a broader patient population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
- Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
- Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):
Key exclusion criteria (8 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
- Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
- Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
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 |
|---|---|---|
| Cetuximab (EGFR inhibitor)Given IV | Drug | Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans), Cohort 2 - (1 Whole Body PET/CT Scan) |
| 18F-NOTA-ABY-030Given Bolus Injection | Drug | Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans), Cohort 2 - (1 Whole Body PET/CT Scan) |
| Positron Emission Tomography (PET)Undergo PET/CT | Procedure or surgery | Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans), Cohort 2 - (1 Whole Body PET/CT Scan) |
Primary outcome
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.
Time frame: From infusion to 7 days post-infusion
As determined by the number of adverse events (AEs) that are possibly or probably related to the study drug within 24 hours after infusion. Dose limiting toxicities will be defined as an AE grade >2 that is clinically significant and attributable to the study drug.
2 secondary outcomes
Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects.
Time frame: From infusion to 7 days post-infusion
Compare sensitivity and specificity of standard of care imaging modalities (MRI, CT, and/or [18F]FDG PET/CT) to [18F]NOTA-ABY-030-PET/CT for detection of indeterminate metastatic and/or primary lesion(s) in HNSCC
Time frame: From infusion to 7 days post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study. Additionally, the data collected may not meet the robustness or generalizability standards required for broader dissemination. The investigators do not plan to share IPD with other researchers at this time.
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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.
Eben Rosenthal, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030 and Positron Emission Tomography (PET) in people with SCC - Squamous Cell Carcinoma and Radiotracer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 May 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Jones (615-936-2807, nicole.l.jones@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects. (time frame: From infusion to 7 days post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.