Not Yet RecruitingPhase 1

ABY-029 Head & Neck Trial

24 participantsStarted 2026-06-30

Plain-language summary

The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach head and neck squamous cell carcinomas (HNSCC) so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx.
✓. Tumor judged to be operable.
✓. Valid informed consent by participant.
✓. Age ≥ 18 years old.
✓. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

✕. Patients with a medical history of (Grade 2 or higher) hepatic/renal function compromise.
✕. Prisoners
✕. Individuals who are pregnant or breast feeding.
✕. Patients on experimental or approved anti-EGFR targeted therapies.

What they're measuring

Adverse events related to ABY-029

Timeframe: one month

Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens

Timeframe: up to three months

Trial details

NCT IDNCT07279116

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Keith D Paulsen, PhD

603-646-2695 keith.d.paulsen@dartmouth.edu

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials