Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental virus therapy VAXINIA tested in advanced cancer patients

NCT ID NCT05346484

Disease control Sponsor: Imugene Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new treatment called VAXINIA (CF33-hNIS), a virus designed to attack cancer cells, in 66 adults with advanced solid tumors that had spread. The treatment was given alone or with the immunotherapy drug pembrolizumab, either as a shot into the tumor or through a vein. The main goal was to check safety and find the best dose, but the study was stopped early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

66 people

The number who actually took part.

Started

May 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bile duct cancer bile duct neoplasm carcinoma cholangiocarcinoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Bile duct cancer Cholangiocarcinoma Metastatic cancer Solid carcinoma Solid tumor Solid tumor, adult

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Highlands Oncology

    Springdale, Arkansas, 72762, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • NEXT Oncology

    Fairfax, Virginia, 22031, United States

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065, Australia

  • Tasman Oncology Research

    Southport, Queensland, 4215, Australia

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698, United States

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724-5024, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.