Phase I Study of RiMO-401 With Radiation in Advanced Tumors

Inclusion Criteria: * Diagnosis of advanced or metastatic cancer not amenable to curative therapy * Lesion that is amenable to palliative radiotherapy * Lesion that is technically feasible for intratumoral injection * Target tumor in region not in the field that was irradiated within the past six months * Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment * Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment * Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion * ECOG score of 0-1 * Have a life expectancy of at least 12 weeks * Have adequate bone marrow reserve and adequate liver function * Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures * Patients must sign a study-specific informed consent form prior to study entry * Age 18 years or older. Exclusion Criteria: * Patients with a histological diagnosis of lymphomas and/or leukemias * Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected * Patients may not have received chemotherapy, targeted therapies, immunotherapies, biologic response modifiers and/or hormonal therapy within the last 14 days * Ongoing clinically significant infection at or near the incident lesion * Major surgery over the target area (excluding placement of vascular access) \<21 days from beginning of the study drug or minor surgical procedures \<7 days * Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study * Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial * Pregnant and nursing women * Patients with a target lesion located in a previously irradiated field * Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.