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

Imugene

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Cancer; Solid Tumor; Bile Duct Cancer; Solid Tumor, Adult; Advanced Solid Tumor; Solid Carcinoma; Cholangiocarcinoma

Treatments: Biological: CF33-hNIS; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05346484

CF33-hNIS-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

CF33-hNIS IT Administration Monotherapy

Experimental group

Treatment:

Biological: CF33-hNIS

CF33-hNIS IV Administration Monotherapy

Experimental group

Treatment:

Biological: CF33-hNIS

CF33-hNIS IT Administration in Combination with Pembrolizumab

Experimental group

Treatment:

Biological: Pembrolizumab

Biological: CF33-hNIS

CF33-hNIS IV Administration in Combination with Pembrolizumab

Experimental group

Treatment:

Biological: Pembrolizumab

Biological: CF33-hNIS