NCT04521764

A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \[DNA\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express NAP (oncolytic measles virus encoding helicobacter pylori neutrophil-activating protein (modified virus strain neutrophil activating protein \[MV-s- NAP) in patients with metastatic breast cancer. II. To determine the safety and toxicity of one-time intratumoral administration of MV-s-NAP in patients with metastatic breast cancer. III. To determine the safety and toxicity of serial intratumoral administration of MV-s-NAP in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. To assess in a preliminary fashion antitumor efficacy of this approach by following radiographic response and time to progression. Ia. Response at and away from the site of MV-s-NAP administration will be evaluated. CORRELATIVE OBJECTIVES: I. To assess viremia, viral replication, and measles virus shedding/persistence following intratumoral administration. II. To determine the time course of viral infection and viral gene expression in treated/untreated lesions. III. To determine immune response development against MV, the therapeutic s-NAP transgene, and the tumor. IV. To obtain preliminary assessments of PD-L1 expression in tumor cells and tumor infiltrating lymphocytes (TILs). OUTLINE: Patients are assigned to 1 of 3 cohorts. COHORT 1: Patients receive MV-s-NAP intratumorally (IT) on day 1 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood and urine sample collection throughout the study. COHORT 2 (CLOSED TO ACCRUAL 6/9/2025): Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood and urine sample collection throughout the study. COHORT 3: Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood and urine sample collection throughout the study. After completion of study treatment, patients are followed up every 3 months during year 1, and then every 6 months during year 2.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Metastatic Breast Adenocarcinoma
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer AJCC v6 and v7

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein	Given IT
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biopsy	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection

Timeline

• Start date: 2020-09-23
• Primary completion: 2027-08-15
• Completion: 2027-08-15
• First posted: 2020-08-21
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study