A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
Reason given: Portfolio prioritization
Key facts
- Where
- Cincinnati, Detroit, Duarte, Fairfax, Grand Rapids, La Jolla, Miami, Salt Lake City, Springdale, and Tucson, United StatesSee the 10 sites
- Phase
- Phase 1
Where in United States
- University of CincinnatiCincinnati, United StatesNo longer taking part
- Barbara Ann Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
- City of Hope Medical CenterDuarte, United StatesNo longer taking part
- NEXT OncologyFairfax, United StatesNo longer taking part
- Corewell HealthGrand Rapids, United StatesNo longer taking part
- UC San Diego Moores Cancer CenterLa Jolla, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Huntsman Cancer InstituteSalt Lake City, United StatesNo longer taking part
- Highlands OncologySpringdale, United StatesNo longer taking part
- University of Arizona Cancer CenterTucson, United StatesNo longer taking part
Trial details
- Who runs it
- Imugene Limited
- Trial code
- NCT05346484
- Record updated
- 6 March 2026
- Original description
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.Read full original descriptionShow less
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).
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.
Inclusion: Written informed consent from patient or legally authorized representative; Age ≥ 18 years old on the date of consent; IT/IV cohorts: 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 (ICI) treatment). Expansion cholangiocarcinoma IT and IV cohorts: one prior line of chemotherapy in metastatic/advanced setting. Patients with targetable tumor mutations must have also received 1 line of approved targeted therapy; Expansion cholangiocarcinoma IV cohort: prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted; ECOG performance status 0 - 2; At least one measurable lesion; For IT administration, ideally < 5 total lesions no greater than 10cm and <33% of liver volume replaced by tumor; 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: 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; Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state; Active autoimmune disease; 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; Inadequate pulmonary function per Investigator assessment; Uncontrolled brain or other central nervous system (CNS) metastases.