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ABY-029 Head & Neck Phase 1 Trial

Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

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

Exclusion Criteria:

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

About the study

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.

What is being tested

• ABY-029 (drug)

Sponsor: Dartmouth-Hitchcock Medical Center · Participants: 24 · Started: Oct 20, 2026

Contact the study team

• Keith D Paulsen, PhD · Phone: 603-646-2695
• Joseph Paydarfar, MD · Phone: 603-650-8123

Official record on ClinicalTrials.gov — NCT07279116

Locations in the U.S.

Conditions

• Head and Neck Squamous Cell Carcinoma

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.