ClinTrial Refer

Trial Acronym
VAXINIA

Registration Number
NCT05346484

Scientific 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.

* 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

* 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 Location Name

Address

Status

Tasman Health Care Gold Coast

7/3/123 Nerang St, Southport QLD 4215, Australia

Recruiting

Primary Contact : Vishal Patel, research@tasmanhealthcare.com.au , +61756132480

Imugene Limited

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT05346484

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT05346484

Secondary IDs
CF33-hNIS-002

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 1

Minimum Age
18

Maximum Age
100

Date Registered
28/08/2025

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
Yes

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Cohort Details

Cohort Name

Description

Status

IV Cholangiocarcinoma Cohort

CF33-hNIS + modified FOLFOX

Open

Discipline

Health Condition

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