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

Phase 1

Completed

• Conditions: Pancreatic Cancer; ColoRectal Cancer; Gastric Cancer; HepatoCellular Carcinoma; Breast Cancer; Esophageal Cancer; Head and Neck Cancer; Ovarian Cancer; Lung Cancer
• Interventions: Biological: INO-1400; Biological: INO-1401; Biological: INO-9012

• Registration Number: NCT02960594
• Lead Sponsor: Inovio Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Status Verified: 2018-11
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 3	INO-1400	2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 3	INO-9012	2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 4	INO-1400	2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 1	INO-1400	2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 2	INO-1400	8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 10	INO-9012	8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 5	INO-1400	8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 9	INO-9012	8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 5	INO-9012	8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 6	INO-9012	8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 6	INO-1400	8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 4	INO-9012	2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 7	INO-1401	2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 8	INO-1401	8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 10	INO-1401	8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 9	INO-1401	8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (6)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States