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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05346484
Other study ID # CF33-hNIS-002
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 17, 2022
Est. completion date January 2025

Study information

Verified date May 2024
Source Imugene Limited
Contact Lisa Guttman
Phone 61 2 9423 0881
Email info@imugene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
CF33-hNIS
CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)
Pembrolizumab
Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

Locations

Country Name City State
Australia St. Vincent's Hospital Fitzroy Victoria
Australia Tasman Oncology Research Southport Queensland
United States University of Cincinnati Cincinnati Ohio
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States City of Hope Medical Center Duarte California
United States NEXT Oncology Fairfax Virginia
United States Corewell Health Grand Rapids Michigan
United States UC San Diego Moores Cancer Center La Jolla California
United States University of Miami Miami Florida
United States Huntsman Cancer Institute Salt Lake City Utah
United States Highlands Oncology Springdale Arkansas
United States University of Arizona Cancer Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Imugene Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other To evaluation antiviral immune activation 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.
Up to 2 years from first dose of study drug.
Primary 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.
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary To evaluate infection of tumors with CF33-hNIS hNIS-based imaging via SPECT technetium-99 (99TC). 21 days from first dose of study drug
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