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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 (MAST)

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ClinicalTrials.gov Identifier: NCT05346484
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Imugene Limited

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Solid Carcinoma Solid Tumor, Adult Metastatic Cancer Advanced Solid Tumor Biological: CF33-hNIS Biological: Pembrolizumab Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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).
Actual Study Start Date : May 17, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CF33-hNIS IT Administration Monotherapy Biological: CF33-hNIS
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Other Names:
  • VAXINIA
  • HOV2

Experimental: CF33-hNIS IV Administration Monotherapy Biological: CF33-hNIS
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Other Names:
  • VAXINIA
  • HOV2

Experimental: CF33-hNIS IT Administration in Combination with Pembrolizumab Biological: CF33-hNIS
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Other Names:
  • VAXINIA
  • HOV2

Biological: Pembrolizumab
Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).
Other Name: KEYTRUDA®

Experimental: CF33-hNIS IV Administration in Combination with Pembrolizumab Biological: CF33-hNIS
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Other Names:
  • VAXINIA
  • HOV2

Biological: Pembrolizumab
Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).
Other Name: KEYTRUDA®




Primary Outcome Measures :
  1. Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 30 days following the last dose of study treatment. ]
    Adverse events will be graded according to CTCAE v5.0.

  2. Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 21-42 days following the first dose of study treatment. ]
    RP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  2. Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  3. Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  4. Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  5. Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  6. To evaluate viral titers of CF33-hNIS [ Time Frame: Up to 2 years from first dose of study drug. ]
    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.

  7. To evaluate infection of tumors with CF33-hNIS [ Time Frame: 21 days from first dose of study drug ]
    hNIS-based imaging via SPECT technetium-99 (99TC).


Other Outcome Measures:
  1. To evaluation antiviral immune activation [ Time Frame: Up to 2 years from first dose of study drug. ]

    Up regulation of PD-L1 expression as compared to baseline in tumor tissue and circulating tumor cells (CTC).

    Analysis of lymphocyte subsets and cytokine profile compared to baseline.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 an 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05346484


Contacts
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Contact: Amanda Seiz 61 3 9824 5254 info@imugene.com

Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Aruna Parikh         
Principal Investigator: Dan Li         
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Kelly Schneider         
Principal Investigator: Hirva Mamdani         
United States, Virginia
NEXT Oncology Recruiting
Fairfax, Virginia, United States, 22031
Contact: Hoda Kassab         
Principal Investigator: Alexander Spira         
Sponsors and Collaborators
Imugene Limited
Additional Information:
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Responsible Party: Imugene Limited
ClinicalTrials.gov Identifier: NCT05346484    
Other Study ID Numbers: CF33-hNIS-002
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imugene Limited:
oncolytic virus
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents