Clinical Trials /

Inovio TRT-001: Telomerase DNA Immunotherapy in Breast, Lung, and Pancreatic Cancers

NCT02327468

Description:

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high risk breast, lung, or pancreatic cancer with no evidence of disease after surgery and adjuvant therapy. Subjects will be enrolled into one of six 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.

Related Conditions:
  • Breast Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Inovio TRT-001: Telomerase DNA <span class="go-doc-concept go-doc-intervention">Immunotherapy</span> in Breast, Lung, and Pancreatic Cancers

Title

  • Brief Title: Inovio TRT-001: Telomerase DNA Immunotherapy in Breast, Lung, and Pancreatic Cancers
  • Official Title: A Study of hTERT Immunotherapy Alone or in Combination With IL12 DNA Followed by Electroporation in Adults With Breast, Lung, or Pancreatic Cancer at High Risk of Relapse Post Definitive Surgery and Adjuvant Therapy
  • Clinical Trial IDs

    NCT ID: NCT02327468

    ORG ID: UPCC 22913

    Trial Conditions

    Breast Cancer

    Lung Cancer

    Pancreatic Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity
    of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects
    with high risk breast, lung, or pancreatic cancer with no evidence of disease after surgery
    and adjuvant therapy. Subjects will be enrolled into one of six 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

    Trial Arms

    Name Type Description Interventions
    Arm1 Experimental 2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4,8, and 12
    Arm 2 Experimental 8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4,8, and 12
    Arm 3 Experimental 2 mg INO-1400+ 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
    Arm 4 Experimental 2 mg INO-1400+ 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
    Arm 5 Experimental 8 mg INO-1400+ 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
    Arm 6 Experimental 8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

    Eligibility Criteria

    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 post
    definitive surgery and adjuvant therapy as described for each indication below:

    Breast carcinoma:

    - Individuals with Stage III or Stage II/axillary node positive disease who are
    s/p definitive surgery and at least 4 and no more than 16 weeks from completion
    of definitive chemotherapy and/or radiation adjuvant therapy at the time of
    signing informed consent (for ER+ or Her2+ positive patients, these patients may
    continue on hormonal therapy or antiHer2 therapy as per standard of care)

    - Subjects with ER/PR/HER2 negative breast cancer (triple negative) of any stage
    who are s/p definitive surgery but with residual microscopic breast cancer in
    surgical specimen following neoadjuvant chemotherapy patient may be at least 4
    and no more than 16 weeks from completion of adjuvant therapy (e.g. radiation)
    at the time of signing informed consent

    - History of neoadjuvant therapy is allowed. A subject receiving ongoing adjuvant
    endocrine (e.g. tamoxifen, anastrazole) therapy or trastuzumab is allowed.

    Lung carcinoma:

    * Individuals with Stage IB, II, or IIIA nonsmall cell carcinoma who are s/p
    definitive surgery and at least 4 and no more than 16 weeks from completion of
    definitive adjuvant therapy at the time of signing informed consent

    Pancreatic carcinoma:

    * Individuals with Stage IIII pancreatic ductal adenocarcinoma who are s/p definitive
    surgery and at least 4 and no more than 16 weeks from completion of definitive
    adjuvant therapy at the time of signing informed consent. (History of neoadjuvant
    therapy is allowed. Neuroendocrine tumors or tumors not of pancreatic origin are not
    allowed)

    4. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

    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 nonsystemic inhaled, topical skin and/or eye dropcontaining
    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

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

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

    Changes in safety laboratory parameters from baseline

    Secondary Outcome Measures

    Time to progression

    Antigen specific cellular immune responses

    Antigen specific ELISA

    H&E stain; immunohistochemistry for CD45, CD3, CD8, FoxP3; and TCRbeta molecular analysis of baseline/archival tumor tissue and relapsed tumor tissue, when possible.

    Trial Keywords

    High risk of relapse

    Post definitive