Preclinical safety assessment of MV-s-NAP, a novel oncolytic measles virus strain armed with an H . pylori immunostimulatory bacterial transgene.
Kimberly B Viker, Michael B Steele, Ianko D Iankov...
https://pubmed.ncbi.nlm.nih.gov/36092362Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID04521764
Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (MV-s-NAP) in Patients With Metastatic Breast Cancer
Led by Mayo Clinic ยท Updated on 2026-01-08
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a modified measles virus called MV-s-NAP as a treatment for patients with invasive breast cancer that has spread to other parts of the body, known as metastatic breast cancer. This phase I trial aims to find the safest and most effective dose of MV-s-NAP when given directly into tumors. The virus has been altered to produce a protein involved in inflammatory reactions, and both the modified and unmodified viruses have shown the ability to destroy breast cancer cells in laboratory and animal studies. Participants are assigned to one of three groups. One group receives a single dose of MV-s-NAP directly into the tumor, while the other groups receive multiple doses every 21 or 14 days, up to three cycles, if no disease progression or unacceptable side effects occur. Throughout the study, patients undergo CT scans, MRI, tumor biopsies, and blood and urine sample collections to monitor the virus's effects and safety. During and after treatment, participants are closely monitored for side effects, tumor response, and immune reactions for up to two years. Follow-up visits occur every three months during the first year and every six months during the second year. The study measures the maximum tolerated dose, tumor response, adverse events, viral presence in the blood, and immune system activity to understand the potential impact of MV-s-NAP on metastatic breast cancer.
CONDITIONS
Brief Title
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years
- For Cohort 1: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic disease
- For Cohorts 2 & 3: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease
- For Cohort 1: Radiographic evidence of distant metastatic disease with two measurable sites
- For Cohorts 2 & 3: Radiographic evidence of distant metastatic or recurrent disease with at least one measurable site
- Prior therapies: progressed through at least one cytotoxic regimen or HER2 directed therapy as applicable
- At least one recurrent/metastatic disease site > 1 cm (> 2 cm for lung lesions) amenable to intratumoral administration
- Absolute neutrophil count (ANC) 1500/uL within 7 days prior to registration
- Platelets 100,000/uL within 7 days prior to registration
- Total bilirubin institutional upper limit of normal within 7 days prior to registration
- AST 2 x upper limit of normal within 7 days prior to registration
- Creatinine 1.5 x upper limit of normal within 7 days prior to registration
- Hemoglobin 9.0 g/dL within 7 days prior to registration
- Negative pregnancy test within 7 days prior to registration for women of childbearing potential
- ECOG performance status 0, 1 or 2
- Ability to provide informed consent
- Willingness to return for follow-up and provide biologic samples
- Life expectancy 12 weeks
- Use of bone modifying agents permitted with prior tolerability
You will not qualify if you...
- Known curative or life-extending standard therapy available
- Clinical or radiographic suspicion of impending visceral crisis
- Active infection within 5 days prior to registration
- History of other malignancy within 5 years except certain skin or cervical cancers
- Recent chemotherapy, immunotherapy, HER2 therapy, targeted therapy, investigational agents, or viral/gene therapy within specified timeframes
- Failure to recover from prior systemic therapy effects
- Severe heart disease or arrhythmias
- Untreated or progressive central nervous system metastases
- Requirement for blood product support
- HIV positive or other immunodeficiency
- History of organ transplantation
- History of chronic hepatitis B or C
- Concurrent investigational or non-FDA approved therapies
- Concurrent medications interfering with the trial
- Use of systemic corticosteroids except topical or inhaled
- Exposure to household contacts under 15 months old or with immunodeficiency
- Allergy or severe reaction to measles vaccine
- Received killed measles vaccine between 1963-1967 without re-immunization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 to 9 weeks depending on cohort
Participants receive intratumoral administration of MV-s-NAP according to their assigned cohort. Cohort 1 receives a single treatment on day 1. Cohort 2 receives treatment every 21 days for up to 3 cycles. Cohort 3 receives treatment every 14 days for up to 3 cycles. Participants undergo CT scans, MRI, tumor biopsy, and blood and urine sample collection throughout treatment.
1 to 3 treatment visits depending on cohort, plus additional imaging and sample collection visits
Follow-up
Duration - Up to 2 years
After treatment completion, participants are followed up every 3 months during the first year, and every 6 months during the second year to monitor safety, tumor response, and immune response.
Visits every 3 months in year 1 and every 6 months in year 2
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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