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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-05-17

Primary completion: 2024-12-01

Study completion finish: 2025-01-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05346484

Intervention or treatment

BIOLOGICAL: CF33-hNIS

BIOLOGICAL: Pembrolizumab

Conditions

• Solid Tumor
• Solid Tumor, Adult
• Metastatic Cancer
• Advanced Solid Tumor
• Cholangiocarcinoma
• Bile Duct Cancer
• Solid Carcinoma

Condition: Solid Tumor, Solid Tumor, Adult and more
BIOLOGICAL: CF33-hNIS and other drugs
Southport, Queensland, Australia and more
Sponsor: Imugene Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Tasman Oncology Research

Research sites nearby

Select from list below to view details:

Tasman Oncology Research
Southport, Queensland, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CF33-hNIS IT Administration Monotherapy Not Specified	BIOLOGICAL: CF33-hNIS CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
EXPERIMENTAL: CF33-hNIS IV Administration Monotherapy Not Specified	BIOLOGICAL: CF33-hNIS CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
EXPERIMENTAL: CF33-hNIS IT Administration in Combination with Pembrolizumab Not Specified	BIOLOGICAL: CF33-hNIS CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
EXPERIMENTAL: CF33-hNIS IV Administration in Combination with Pembrolizumab Not Specified	BIOLOGICAL: CF33-hNIS CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	From first dose of study drug through 30 days following the last dose of study treatment.
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.	From first dose of study drug through 21-42 days following the first dose of study treatment.

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab	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.	Up to 2 years from first dose of study drug.
Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.	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.	Up to 2 years from first dose of study drug.
Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.	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.	Up to 2 years from first dose of study drug.
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.	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.	Up to 2 years from first dose of study drug.
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.	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.	Up to 2 years from first dose of study drug.
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.	Up to 2 years from first dose of study drug.
To evaluate infection of tumors with CF33-hNIS	hNIS-based imaging via SPECT technetium-99 (99TC).	21 days from first dose of study drug

Frequently Asked Questions

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References

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