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ACTIVE NOT RECRUITING
NCT03832855
PHASE1

Assessing the Immunogenicity of pING-hHER3FL

Sponsor: Herbert Lyerly

View on ClinicalTrials.gov

Summary

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.

Official title: Assessing the Immunogenicity of pING-hHER3FL in Patients With Resected Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2020-07-13

Completion Date

2030-03

Last Updated

2025-07-03

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

pING-hHER3FL

Plasmid vaccine containing HER3

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States