Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

Inclusion Criteria:

- Have recently diagnosed (< than 6 months prior to screening visit date),
pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx,
hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects
with a history of surgical management (approximately 4-6 weeks before RT with
sufficient time for post-surgical healing) are eligible

- Have a plan to receive a continuous course of conventional external beam irradiation
delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.

- Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to
100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin
regimen administered weekly (100 mg/m2)

- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

- CRP < 80 mg/L

- Have adequate hematopoietic, hepatic, and renal function at the screening visit

Exclusion Criteria:

- Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor

- Metastatic disease (M1) Stage IV C

- Any prior history of head and neck cancer

- Prior radiation to the head and neck

- Have had a major surgical procedure, other than for HNC, or significant traumatic
injury within 4 weeks prior to the initiation of RT; or anticipation of need for a
major surgical procedure during the clinical trial

- Active infectious disease, excluding oral candidiasis

- Have OM at the screening visit

- Have a history of hypersensitivity to monoclonal antibody