A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

The investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a
diagnosis of operable head and neck cancer in this open label, single center, clinical trial
of ABY-029.

Administration of ABY-029 will occur as a single intravenous injection to subjects with
operable head and neck cancer approximately 1-3 hours prior to surgery.

Documentation of the tumor with digital photography will be performed at several time points
during surgery: pre-resection, at intermediate time points during surgery, and
post-resection. White light assessment of the tumor and boundaries will be performed by the
surgeon.

Intraoperative optical probe measurements will occur in areas of visible tumor as well as
normal appearing tissue. At multiple time points during each surgery and at the discretion of
the surgeon, optical probe measurements will be completed with the probe followed by biopsy
sampling of the same sites when they are intended for resection. Commonly, these acquisitions
will occur at first exposure of the tumor, at the approximate mid-point of tumor resection
(when a significant amount of tumor tissue is present in the operative field), at a point
nearing but prior to completion of tumor resection (when a small amount of tumor tissue is
presumably present), and at the intended completion of tumor resection (when residual tumor
may or may not exist). At a data collection time point, optical probe measurements will be
performed and archived for analysis and locations may be biopsied when tissue is intended for
resection.

Any normal tissue removed as part of surgical procedure will be sampled. Samples may be taken
from tissue outside the "antic" tumor volume but resected as part of the procedure along the
surgical corridor. All tissue collected will be submitted to pathology for routine
processing.

After tissue is removed breadloafed sections will be placed on a fluorescence scanning imager
for complete measurement of signal on the exposed surfaces. Pathological analysis for EGFR
status will be completed at selected regions around the faces of each breadloaf section.

The protocol is not a safety study since no physiological effects are expected at microdose
levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can
be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is
considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a
tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or
therapeutic intent is proposed, and study drug administration is not intended to alter the
extent of planned tumor resection during the surgical procedure.

Inclusion Criteria:

1. Preoperative diagnosis of head and neck cancer.

2. Tumor judged to be operable based on preoperative imaging studies.

3. Valid informed consent by subject or subject's Legally Authorized Representative.

4. Age ≥ 18 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.

2. Patients on any experimental anti-EGFR targeted therapies, either investigational or
FDA approved.