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NCT03832855 · ClinicalTrials.gov registry record · Phase 1
Assessing the Immunogenicity of pING-hHER3FL
A Phase 1 study of Advanced Cancer, sponsored by Herbert Lyerly.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03832855: Active Phase 1 study of Advanced Cancer, sponsored by Herbert Lyerly.
NCT03832855 is a Phase 1 study of Advanced Cancer that is active but no longer recruiting, run by Herbert Lyerly. The registered enrollment target is 10 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03832855, a Phase 1 study of Advanced Cancer, is active but no longer recruiting, sponsored by Herbert Lyerly.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
B cell and T cell specific immune response to pING-hHER3FL vaccinationvaccination
Conditions Studied
Interventions
- BIOLOGICAL pING-hHER3FL
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2030-03 |
| Phase | Phase 1 |
What the registry record for NCT03832855 still lists
NCT03832855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which pING-hHER3FL is the first listed.
NCT03832855 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03832855 about?
NCT03832855 is a clinical study titled "Assessing the Immunogenicity of pING-hHER3FL". 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...
What is the current status of trial NCT03832855?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-07-13. Estimated completion is 2030-03.
What conditions does trial NCT03832855 study?
This clinical trial studies the following conditions: Advanced Cancer.
What interventions are being tested in trial NCT03832855?
The interventions under investigation include: pING-hHER3FL (BIOLOGICAL).
Who is sponsoring clinical trial NCT03832855?
This trial is sponsored by Herbert Lyerly, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03832855 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03832855's enrollment target sits among peer trials
10 119th of 122 higher than 3 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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