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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05346484




Registration number
NCT05346484
Ethics application status
Date submitted
22/03/2022
Date registered
26/04/2022
Date last updated
16/05/2024

Titles & IDs
Public title
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
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).
Secondary ID [1] 0 0
CF33-hNIS-002
Universal Trial Number (UTN)
Trial acronym
MAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Solid Carcinoma 0 0
Solid Tumor, Adult 0 0
Metastatic Cancer 0 0
Advanced Solid Tumor 0 0
Cholangiocarcinoma 0 0
Bile Duct Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CF33-hNIS
Other interventions - Pembrolizumab

Experimental: CF33-hNIS IT Administration Monotherapy -

Experimental: CF33-hNIS IV Administration Monotherapy -

Experimental: CF33-hNIS IT Administration in Combination with Pembrolizumab -

Experimental: CF33-hNIS IV Administration in Combination with Pembrolizumab -


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

Other interventions: Pembrolizumab
Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab
Timepoint [1] 0 0
From first dose of study drug through 30 days following the last dose of study treatment.
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab
Timepoint [2] 0 0
From first dose of study drug through 21-42 days following the first dose of study treatment.
Secondary outcome [1] 0 0
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab
Timepoint [1] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [2] 0 0
Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Timepoint [2] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [3] 0 0
Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Timepoint [3] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [4] 0 0
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Timepoint [4] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [5] 0 0
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Timepoint [5] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [6] 0 0
To evaluate viral titers of CF33-hNIS
Timepoint [6] 0 0
Up to 2 years from first dose of study drug.
Secondary outcome [7] 0 0
To evaluate infection of tumors with CF33-hNIS
Timepoint [7] 0 0
21 days from first dose of study drug

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Imugene Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 in patients with metastatic or advanced solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05346484
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Guttman
Address 0 0
Country 0 0
Phone 0 0
61 2 9423 0881
Fax 0 0
Email 0 0
info@imugene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05346484