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Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC

NCT02531425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-15

No results posted yet for this study

Summary

Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single 28-day cycle.

Conditions

  • ER-Negative PR-Negative HER2-Negative Breast Cancer

Interventions

BIOLOGICAL

IT-pIL12-EP

Intratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions

Sponsors & Collaborators

  • OncoSec Medical Incorporated

    lead INDUSTRY

Principal Investigators

  • Sharron Gargosky, PhD · OncoSec Medical Incorporated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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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 NCT02531425 on ClinicalTrials.gov