AzTrials
AzTrials

Solid TumorPhase 1MASTNCT05346484

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

A Phase 1 study testing CF33-hNIS, Pembrolizumab and Modified FOLFOX in people with Solid Tumor and Solid Carcinoma, run by Imugene Limited at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Solid Carcinoma, Solid Tumor, Adult
What is being tested?
CF33-hNIS, Pembrolizumab and Modified FOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
12 sitesin 2 countries
Study dates
17 May 2022to 12 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States10 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope Medical Center

    Duarte, California, 91010

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

  • University of Miami

    Miami, Florida, 33136

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Highlands Oncology

    Springdale, Arkansas, 72762

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724-5024

Other trials in United States

Australia2 sites

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Tasman Oncology Research

    Southport, Queensland, 4215

Other trials in Australia

About this study

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).

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 the detailed description

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

Patients eligible for treatment in dose escalation IT/IV cohorts 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(ICI). For expansion IT and IV cholangiocarcinoma cohort patients, one prior line of systemic chemotherapy in metastatic/advanced setting is required and for patients with targetable tumor mutations, must have also received 1 line of an approved targeted therapy. For expansion IV cholangiocarcinoma cohort, prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted.

For IT/IV cohorts, 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 with pembrolizumab will also receive pembrolizumab Day 1 of each cycle beginning with Cycle 2.

For IV cholangiocarcinoma expansion cohort, patients will be treated with CF33-hNIS on Day 3 and Day 17 of each 28 day cycle along with a modified FOLFOX regimen.

Being tested
CF33-hNIS, Pembrolizumab, Modified FOLFOX
Keywords
oncolytic virus
Medical subject headings
Neoplasm Metastasis, Cholangiocarcinoma, Bile Duct Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF33-hNISBiological

    Also called VAXINIA, HOV2

    CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)

  • PembrolizumabBiological

    Also called KEYTRUDA®

    Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

  • Modified FOLFOXDrug

    28 day cycle of:

    • Leucovorin calcium/folinic acid
    • Fluorouracil
    • oxaliplatin
Study groups in NCT05346484
Study groupRoleWhat they receive
CF33-hNIS IT Administration MonotherapyExperimentalNot described
Receives: Biological: CF33-hNIS
CF33-hNIS IV Administration MonotherapyExperimentalNot described
Receives: Biological: CF33-hNIS
CF33-hNIS IT Administration in Combination with PembrolizumabExperimentalNot described
Receives: Biological: CF33-hNIS; Biological: Pembrolizumab
CF33-hNIS IV Administration in Combination with PembrolizumabExperimentalNot described
Receives: Biological: CF33-hNIS; Biological: Pembrolizumab
CF33-hNIS IV Administration in Combination with modified FOLFOXExperimentalNot described
Receives: Biological: CF33-hNIS; Drug: Modified FOLFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From first dose of study drug through 30 days following the last dose of study treatment.

  2. 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.

    Measured: From first dose of study drug through 21-42 days following the first dose of study treatment.

Secondary outcomes (7)

  1. Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX

    ORR is defined as the proportion of patients in the efficacy population who achieve a radiographic Investigator-assessed confirmed complete response (CR) or partial response (PR), per RECIST v1.1 or confirmed immune complete response (iCR) or immune partial response (iPR) per iRECIST v1.0.

    Measured: Up to 2 years from first dose of study drug.

  2. Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX

    PFS, defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first.

    Measured: Up to 2 years from first dose of study drug.

  3. Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX

    defined as the time from the start of treatment until death due to any cause. Median OS and OS rate at 12 months will be reported.

    Measured: Up to 2 years from first dose of study drug.

  4. Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX

    DOR is defined as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause.

    Measured: Up to 2 years from first dose of study drug.

  5. Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOX

    DCR is defined as the proportion of patients who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0.

    Measured: Up to 2 years from first dose of study drug.

  6. To evaluate viral titers of CF33-hNIS

    Viral Plaque Assay (VPA) and polymerase chain reaction (PCR) testing from serum, urine, oral swab, rectal swab, injection site(s) swab and wound dressing swab.

    Measured: Up to 2 years from first dose of study drug.

  7. To evaluate infection of tumors with CF33-hNIS

    hNIS-based imaging via SPECT technetium-99 (99TC).

    Measured: 21 days from first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start17 May 2022
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

Why it stopped: Portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346484
Sponsor's protocol ID
CF33-hNIS-002
Acronym
MAST
Status last verified
Jun 2025
First submitted
22 Mar 2022
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CF33-hNIS, Pembrolizumab and Modified FOLFOX in people with Solid Tumor and Solid Carcinoma, run by Imugene Limited at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab (time frame: From first dose of study drug through 30 days following the last dose of study treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in