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NCT Number: NCT02960594

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

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INO-1400

Biological

Other names: hTERT

INO-9012

Biological

Other names: IL-12

INO-1401

Biological

Other names: SynCon TERT

Primary outcomes

  1. Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03

    Time frame: Up to 2 years from first study treatment

  2. Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site

    Time frame: Up to 14 weeks

  3. Changes in safety laboratory parameters

    Time frame: Up to 2 years from first study treatment

Sponsors and collaborators

Lead sponsor

Inovio Pharmaceuticals

Industry

Collaborators

  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic
  • Thomas Jefferson University
  • University of North Carolina
  • University of Pennsylvania
  • University of Pittsburgh

Registry information

Official study title

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

Acronym: TRT-001

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2016
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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