Status:
ACTIVE_NOT_RECRUITING
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
Lead Sponsor:
Imugene Limited
Conditions:
Solid Tumor
Solid Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05346484
Start Date
May 17 2022
End Date
November 1 2026
Last Update
January 5 2026
Active Locations (12)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
2
Highlands Oncology
Springdale, Arkansas, United States, 72762
3
City of Hope Medical Center
Duarte, California, United States, 91010
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698