A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST).
| ClinicalTrials.gov Identifier |
| NCT05346484 |
| Institution Name |
| City of Hope Medical Center |
| Full Institution Address |
|
1500 East Duarte Road Duarte California 91010 United States |
| Principal Investigator |
| Dr. Dan Li |
| Principal Investigator Phone |
| (626) 471-9200 |
| Study Coordinator |
| Aruna Parikh |
| Study Coordinator Phone |
| (626) 471-9200 |
| Study Coordinator Email |
| arparikh@coh.org |
| Additional Study Coordinators |
|
| Study Overview |
| Open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors. |
| Enrollment Information |
| approximately 100 |
| Study Start Date |
| 20220517 |
| Study End Date |
| 20251031 |
| Inclusion 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 |
| Exclusion Criteria |
| 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 |
| Financial Assistance Available |
| Yes |