Study Stopped
Portfolio prioritization
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
MAST
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).
1 other identifier
interventional
66
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2026
CompletedMarch 6, 2026
June 1, 2025
3.7 years
March 22, 2022
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab
Adverse events will be graded according to CTCAE v5.0.
From first dose of study drug through 30 days following the last dose of study treatment.
Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab
RP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data.
From first dose of study drug through 21-42 days following the first dose of study treatment.
Secondary Outcomes (7)
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX
Up to 2 years from first dose of study drug.
Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX
Up to 2 years from first dose of study drug.
Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX
Up to 2 years from first dose of study drug.
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX
Up to 2 years from first dose of study drug.
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX
Up to 2 years from first dose of study drug.
- +2 more secondary outcomes
Other Outcomes (1)
To evaluate antiviral immune activation
Up to 2 years from first dose of study drug.
Study Arms (5)
CF33-hNIS IT Administration Monotherapy
EXPERIMENTALCF33-hNIS IV Administration Monotherapy
EXPERIMENTALCF33-hNIS IT Administration in Combination with Pembrolizumab
EXPERIMENTALCF33-hNIS IV Administration in Combination with Pembrolizumab
EXPERIMENTALCF33-hNIS IV Administration in Combination with modified FOLFOX
EXPERIMENTALInterventions
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).
28 day cycle of: * Leucovorin calcium/folinic acid * Fluorouracil * oxaliplatin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imugene Limitedlead
Study Sites (12)
University of Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Highlands Oncology
Springdale, Arkansas, 72762, United States
City of Hope Medical Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
University of Miami
Miami, Florida, 33136, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
NEXT Oncology
Fairfax, Virginia, 22031, United States
Tasman Oncology Research
Southport, Queensland, 4215, Australia
St. Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2022
First Posted
April 26, 2022
Study Start
May 17, 2022
Primary Completion
January 12, 2026
Study Completion
January 12, 2026
Last Updated
March 6, 2026
Record last verified: 2025-06