ABY-029 Head & Neck Trial

ConditionHead and Neck Squamous Cell Carcinoma

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorDartmouth-Hitchcock Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: ABY-029 6X dose groupExperimental treatment 1 intervention

Group B: ABY-029 10X dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse events related to ABY-029

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.

Time frame

one month

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

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.

Time frame

up to three months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Dartmouth College

Collaborator

National Cancer Institute (NCI)