for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around
Principal Investigator
by Gregory Daniels, MD, PhD
Headshot of Gregory Daniels
Gregory Daniels



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 in patients with metastatic or advanced solid tumors.

Official Title

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).


CF33-hNIS, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with pembrolizumab to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment.

Patients eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy which may have included treatment with an Immune Checkpoint Inhibitor.

All enrolled patients will be treated with CF33-hNIS on Day 1 and 8 of Cycle 1 and then on Day 1 of each cycle thereafter. Patients treated with the combination regimen will also received pembrolizumab beginning on Day 1 of each cycle beginning with Cycle 2.


Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer, Advanced Solid Tumor, Cholangiocarcinoma, Bile Duct Cancer, oncolytic virus, Neoplasms, Bile Duct Neoplasms, Pembrolizumab, CF33-hNIS, CF33-hNIS IT Administration Monotherapy, CF33-hNIS IV Administration Monotherapy


You can join if…

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

You CAN'T join 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


  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093-0698 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSD

  • Gregory Daniels, MD, PhD
    Dr. Daniels coordinates our clinical program in melanoma. His own research involves understanding the link between autoimmunity and tumor immunity in developing more effective and less toxic vaccines and immune stimulatory approaches for patients with melanoma.


accepting new patients
Start Date
Completion Date
Imugene Limited
Imugene Limited (ASX: IMU) is a publicly-listed Australian biotechnology company developing cancer immunotherapies.
Phase 1 research study
Study Type
Expecting 100 study participants
Last Updated