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

Launched by IMUGENE LIMITED · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CF33-hNIS (VAXINIA), which is an oncolytic virus designed to target and kill cancer cells, particularly in patients with advanced solid tumors like metastatic cancer. The trial is looking at how safe this treatment is when given alone or combined with another medication called pembrolizumab, which helps the body’s immune system fight cancer. Participants in this study will receive the treatment either directly into their tumor or through an intravenous (IV) line.

To join the trial, patients need to be at least 18 years old and have a type of cancer that has worsened despite receiving at least two previous treatments. They must also have good overall health and meet certain medical criteria. Throughout the study, participants will have regular visits for treatment and tests to monitor their health. It's important to know that some patients may not be eligible due to specific medical conditions or recent treatments. This trial is currently recruiting participants, and it offers a potential new option for those struggling with advanced cancer.

Gender

ALL

Eligibility criteria

• 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