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Examining Bioactivity of PVSRIPO in Invasive Breast Cancer

NCT03564782 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-02-08

Study results available
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Summary

This is a pilot study to examine PVSRIPO bioactivity in tumor tissue after intratumoral administration of PVSRIPO in women with invasive breast cancer.

Conditions

Interventions

BIOLOGICAL

PVSRIPO

The live, attenuated, oral (Sabin), serotype 1 poliovirus vaccine booster will be administered 1 week before PVSRIPO injection. The study drug, PVSRIPO, is the live attenuated, oral (Sabin) serotype 1 poliovirus vaccine containing a heterologous internal ribosomal entry site (IRES) derived from the human rhinovirus type 2 (HRV2). It will be given at a dose of 1x10\^8 TCID50 (tissue culture infectious dose) directly into the breast tumor.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Istari Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Darell Bigner, MD, PhD · Istari Oncology, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2022-04-11
Completion
2022-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564782 on ClinicalTrials.gov