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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02960594

Acronym

TRT-001

Enrollment

Registered

2016-11-09

Start date

2014-12-31

Completion date

2018-11-09

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Immunotherapy, Human Telomerase Reverse Transcriptase (hTERT), Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, High Risk of Relapse, Post Definitive Surgery, Post Adjuvant Therapy, No Evidence of Disease

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.

Interventions

BIOLOGICALINO-1400

BIOLOGICALINO-9012

BIOLOGICALINO-1401

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 1\. Signed and dated written IRB approved informed consent; * 2\. Males or females aged ≥18 years; * 3\. 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

Exclusion criteria

* 1\. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy; * 2\. 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; * 3\. Administration of any vaccine within 4 weeks of the first study treatment

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026