CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 5 enrolled
Drug / intervention
PVSRIPObiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03564782
NCT03564782Early Ph 1Completed
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Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Invasive Breast Cancer

Istari Oncology, Inc.·interventional·Posted Jun 21, 2018·Updated Feb 8, 2024

In Brief

A Early Phase 1 clinical trial evaluating PVSRIPO for Invasive Breast Cancer. Completed, enrolled 5 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Breast Cancer
CountriesUnited States
CollaboratorsDuke University, United States Department of Defense

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJun 21, 2018
Enrollment StartJun 30, 2019
Primary CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.0 years ago

Interventions

PVSRIPObiological

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.