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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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CF33-hNIS, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with pembrolizumab or mFOLFOX to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment.

Patients eligible for treatment in dose escalation IT/IV cohorts 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(ICI). For expansion IT and IV cholangiocarcinoma cohort patients, one prior line of systemic chemotherapy in metastatic/advanced setting is required and for patients with targetable tumor mutations, must have also received 1 line of an approved targeted therapy. For expansion IV cholangiocarcinoma cohort, prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted.

For IT/IV cohorts, 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 with pembrolizumab will also receive pembrolizumab Day 1 of each cycle beginning with Cycle 2.

For IV cholangiocarcinoma expansion cohort, patients will be treated with CF33-hNIS on Day 3 and Day 17 of each 28 day cycle along with a modified FOLFOX regimen.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CF33-hNIS IT Administration Monotherapy

Group Type EXPERIMENTAL

CF33-hNIS

Intervention Type BIOLOGICAL

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

CF33-hNIS IV Administration Monotherapy

Group Type EXPERIMENTAL

CF33-hNIS

Intervention Type BIOLOGICAL

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

CF33-hNIS IT Administration in Combination with Pembrolizumab

Group Type EXPERIMENTAL

CF33-hNIS

Intervention Type BIOLOGICAL

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

Pembrolizumab

Intervention Type BIOLOGICAL

Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

CF33-hNIS IV Administration in Combination with Pembrolizumab

Group Type EXPERIMENTAL

CF33-hNIS

Intervention Type BIOLOGICAL

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

Pembrolizumab

Intervention Type BIOLOGICAL

Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

CF33-hNIS IV Administration in Combination with modified FOLFOX

Group Type EXPERIMENTAL

CF33-hNIS

Intervention Type BIOLOGICAL

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

Modified FOLFOX

Intervention Type DRUG

28 day cycle of:

* Leucovorin calcium/folinic acid
* Fluorouracil
* oxaliplatin

Interventions

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CF33-hNIS

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

Intervention Type BIOLOGICAL

Pembrolizumab

Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

Intervention Type BIOLOGICAL

Modified FOLFOX

28 day cycle of:

* Leucovorin calcium/folinic acid
* Fluorouracil
* oxaliplatin

Intervention Type DRUG

Other Intervention Names

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VAXINIA HOV2 KEYTRUDA®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No