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

Overview

Información sobre este estudio

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 solid tumor cancer with no evidence of disease after surgery and standard 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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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:
    1. Breast carcinoma:
    2. Lung carcinoma:
    3. Pancreatic carcinoma:
    4. Head and neck squamous cell carcinoma:
    5. Ovarian cancer:
    6. Colorectal cancer
    7. Gastric and esophageal cancer
    8. 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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Ashish Chintakuntlawar, M.B.B.S., Ph.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Ashish Chintakuntlawar, M.B.B.S., Ph.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20271975

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