hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
TRT-001
A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy
1 other identifier
interventional
93
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Dec 2014
Typical duration for phase_1 breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedNovember 19, 2018
November 1, 2018
3.9 years
November 4, 2016
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Up to 2 years from first study treatment
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
Up to 14 weeks
Changes in safety laboratory parameters
Up to 2 years from first study treatment
Study Arms (10)
Arm 1
EXPERIMENTAL2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 2
EXPERIMENTAL8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 3
EXPERIMENTAL2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 4
EXPERIMENTAL2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 5
EXPERIMENTAL8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 6
EXPERIMENTAL8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 7
EXPERIMENTAL2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 8
EXPERIMENTAL8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 9
EXPERIMENTAL8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 10
EXPERIMENTAL8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Interventions
Eligibility Criteria
You may qualify if:
- \. Signed and dated written IRB approved informed consent;
- \. Males or females aged ≥18 years;
- \. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:
- Breast carcinoma:
- Lung carcinoma:
- Pancreatic carcinoma:
- Head and neck squamous cell carcinoma:
- Ovarian cancer:
- Colorectal cancer
- Gastric and esophageal cancer
- Hepatocellular carcinoma
You may not qualify if:
- \. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
- \. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
- \. Administration of any vaccine within 4 weeks of the first study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inovio Pharmaceuticalslead
- University of Pennsylvaniacollaborator
- University of North Carolinacollaborator
- Thomas Jefferson Universitycollaborator
- University of Pittsburghcollaborator
- Barbara Ann Karmanos Cancer Institutecollaborator
- Mayo Cliniccollaborator
Study Sites (6)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Vonderheide, MD, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Autumn McRee, MD
University of North Carolina
- PRINCIPAL INVESTIGATOR
Jennifer Johnson, MD
Thomas Jefferson University Hospitial
- PRINCIPAL INVESTIGATOR
Anthony Shields, MD
Karmanos Cancer Center (Wayne State University)
- PRINCIPAL INVESTIGATOR
Nathan Bahary, MD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Ashish Chintakuntlawar, MBBS, PhD
Mayo Clinic, Rochester, MN
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2016
First Posted
November 9, 2016
Study Start
December 1, 2014
Primary Completion
November 9, 2018
Study Completion
November 9, 2018
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share