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)

Inovio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Esophageal Cancer; Gastric Cancer; Lung Cancer; Ovarian Cancer; Head and Neck Cancer; HepatoCellular Carcinoma; ColoRectal Cancer; Pancreatic Cancer

Treatments: Biological: INO-9012; Biological: INO-1401; Biological: INO-1400

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02960594

TRT-001

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 10 patient groups

Arm 1

Experimental group

Description:

2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Arm 2

Experimental group

Description:

8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Arm 3

Experimental group

Description:

2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Biological: INO-9012

Arm 4

Experimental group

Description:

2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Biological: INO-9012

Arm 5

Experimental group

Description:

8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Biological: INO-9012

Arm 6

Experimental group

Description:

8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1400

Biological: INO-9012

Arm 7

Experimental group

Description:

2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1401

Arm 8

Experimental group

Description:

8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1401

Arm 9

Experimental group

Description:

8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1401

Biological: INO-9012

Arm 10

Experimental group

Description:

8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Treatment:

Biological: INO-1401

Biological: INO-9012