A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

Eligibility Criteria

• * Written informed consent from patient or legally authorized representative
• * Age ≥ 18 years old on the date of consent
• * Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment)
• * ECOG performance status 0 - 2
• * At least one measurable lesion
• * Adequate renal function
• * Adequate liver function
• * Adequate hematologic function
• * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• * Prior treatment with a poxvirus based oncolytic virus.
• * Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
• * Prior radiotherapy within 2 weeks of start of study treatment.
• * Active autoimmune disease
• * Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state
• * Inadequate pulmonary function per Investigator assessment.
• * Uncontrolled brain or other central nervous system (CNS) metastases.
• * History of documented congestive heart failure (New York Heart Association \[NYHA\] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias