RiMO-HNC-NEO1: Phase 2 Study of RiMO-301 and Hypofractionated Radiotherapy With Pembrolizumab for the Neoadjuvant Treatment of Resectable, Locally Advanced Head-Neck Cancer

Inclusion Criteria: * Diagnosis of head and neck cancer that requires surgical resection * Must have at least one lesion that is clinically accessible to RiMO-301 injection and amenable to receiving hypofractionated radiotherapy * The selected target lesions must be measurable on cross-sectional imaging, and repeated measurements at the same location should be achievable * Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection, and with no complications from the prior radiation course * Patients must have recovered from acute toxic effects (≤ grade 1 CTCAEv6) of previous cancer treatments prior to enrollment * Patients with locally advanced, resectable head and neck cancer: * suitable to receive a PD-1 inhibitor (pembrolizumab) as a standard of care in the discretion of the treating physician or Principal Investigator * suitable to receive hypofractionated radiotherapy as a standard of care in the discretion of the treating physician or Principal Investigator * Have adequate bone marrow reserve: * Absolute neutrophil count ≥1.5x109 cell/L * Platelet count ≥100x109 cell/L * Hemoglobin at least ≥9.0 g/dL unless confirmed by treating physician as not posing any increased harm to patient and approved by Sponsor (transfusion is allowed to achieve hemoglobin of ≥9.0 g/dL 14-days prior to dosing) * Have adequate liver function: * Total serum bilirubin no more than 1.5x upper limit of normal (ULN)…