Recruiting
Phase 1

ABY-029

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07279116

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABY-029

Study Details

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT07279116

Start date

Oct 20, 2026

Status verified date

Nov, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: ABY-029 6X dose group

ABY-029 will be administered at the 6X dose level prior to surgery to participants with HNSCC.

To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.

experimental: ABY-029 10X dose group

ABY-029 will be administered at the 10X dose level prior to surgery to participants with HNSCC.

To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.

Interventions

ABY-029

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 outcome measure

  • Adverse events related to ABY-029 [ Time Frame: one month ]
  • Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens [ Time Frame: up to three months ]

Central Contacts and Locations

Central contacts

Keith D Paulsen, PhD

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

Joseph Paydarfar, MD

603-650-8123joseph.a.paydarfar@hitchcock.org

Locations

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • ABY-029
  • Affibody
  • Molecular Fluorescence-Guided Surgery
  • Epidermal Growth Factor Receptor (EGFR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.