Assessing the Immunogenicity of pING-hHER3FL (NCT03832855)
🩺 Plain-English Summary (8th-Grade Level)
This study is a phase I clinical trial will that will use an investigational cancer vaccine called pING-hHER3FL. pING-hHER3FL is a circular piece of DNA that produces the full length human HER3 protein and will be used in a phase I study as immunotherapeutic agent to target cancers that are known to express the human epidermal growth factor receptor HER3. The human epidermal growth factor receptor (HER) family including: HER1 (also known as EGFR), HER2, HER3 and HER4 (also known as ErbB2, ErbB3, and ErbB4 respectively) is an important receptor family for the development of many malignancies. HER3 is overexpressed in breast, lung, gastric, head and neck, ovarian cancer, and melanoma. The objectives of this clinical study is to determine the safety and tolerability of pING-hHER3FL in patients with solid tumor malignancies that have been removed surgically and to test whether immunization with pING-hHER3FL can cause a HER3 specific immune response in patients. Patients enrolled in the study will receive pING-hHER3FL by intramuscular injection (IM) every 4 weeks for 3 total doses. Potential benefits of the research include learning the safety of a vaccine targeting HER3 expressing cancers, whether the pING-hHER3FL vaccine can induce HER3 specific immune responses, and see possible clinical benefit to patients receiving pING-hHER3FL.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (12 items).
Location: Duke University Medical Center — Durham, North Carolina
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients must have recovered to Grade 1 toxicities from any prior treatment(s).
- Known CNS/brain metastases
- History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Serious chronic or acute illness considered by the Principal Investigator to constitute an unwarranted high risk for investigational treatment.
- Medical or psychological impediment to probable compliance with the protocol.
- Concurrent or prior second malignancy (within the past 5 years) other than non-melanoma skin cancer, Carcinoma in situ of the bladder and cervix.
- Presence of active infection or systemic use of antimicrobials within 48 hours prior to the start of study treatment.
- Patients on continuous steroid therapy for at least 72 hours (or other continuous immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression.
- Presence of a known active acute or chronic infection including HIV or viral hepatitis (Hepatitis B and C).
- Pregnant or nursing women.
- Prior immunotherapy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Duke University Medical Center — Durham, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.