Solid Tumor Clinical Trial
— MASTOfficial 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).
Verified date | May 2024 |
Source | Imugene Limited |
Contact | Lisa Guttman |
Phone | 61 2 9423 0881 |
info[@]imugene.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Imugene Limited |
United States, Australia,
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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