Clinical trialPhase 1Completed
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
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
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- December 2014
- Expected end
- 9 November 2018
- Enrollment
- 93 participants
- Sites
- 6
- Primary outcomes
- 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
- Sponsor
- Industry
- Results posted
- No
- Last update
- 19 November 2018
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Brief summary public domain (ClinicalTrials.gov)
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.