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

Open to people ages 18 years and up

• 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