hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse

Summary

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

Conditions

• Breast Cancer
• Lung Cancer
• Pancreatic Cancer
• Head and Neck Cancer
• Ovarian Cancer
• ColoRectal Cancer
• Gastric Cancer
• Esophageal Cancer
• HepatoCellular Carcinoma

Interventions

BIOLOGICAL

INO-1400

BIOLOGICAL

INO-9012

BIOLOGICAL

INO-1401

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Barbara Ann Karmanos Cancer Institute

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Inovio Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Robert Vonderheide, MD, PhD · University of Pennsylvania

• Autumn McRee, MD · University of North Carolina

• Jennifer Johnson, MD · Thomas Jefferson University Hospitial

• Anthony Shields, MD · Karmanos Cancer Center (Wayne State University)

• Nathan Bahary, MD · University of Pittsburgh

• Ashish Chintakuntlawar, MBBS, PhD · Mayo Clinic, Rochester, MN

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2018-11-09

Completion

2018-11-09

Countries

• United States

Study Locations