ABY-029 Head & Neck Trial

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABY-029

Drug

ABY-029 will be administered via single intravenous injection to subjects with HNSCC approximately 1-3 hours prior to surgery.

All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices.

No follow-up visit will be required of participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.

Primary outcomes

Adverse events related to ABY-029

Time frame: one month

To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens

Time frame: up to three months

To measure the diagnostic performance of ABY-029, the diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens histologically confirmed as tumor from participants receiving the 6X microdose and 10X microdose.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Paydarfar, MD

CONTACT

[email protected]

603-650-8123

Keith D Paulsen, PhD

CONTACT

[email protected]

603-646-2695

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

Dartmouth College
National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Dec 12, 2025
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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