Status:
NOT_YET_RECRUITING
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Conditions:
SCC - Squamous Cell Carcinoma
Radiotracer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 carcinom...
Eligibility Criteria
Inclusion
- 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
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- Potassium
- Magnesium
- Phosphorus
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07217028
Start Date
January 1 2026
End Date
April 1 2031
Last Update
November 14 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232