Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma

Обзор

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.

Вмешательства

• Препарат Cetuximab (EGFR inhibitor)
  Given IV
• Препарат 18F-NOTA-ABY-030
  Given Bolus Injection
• Процедура Positron Emission Tomography (PET)
  Undergo PET/CT

Первичные конечные точки

• Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects. [Срок оценки: From infusion to 7 days post-infusion]

Вторичные конечные точки (2)

• Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects. [Срок оценки: 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 [Срок оценки: From infusion to 7 days post-infusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07217028 · VICCHNP25055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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