Assessing the Immunogenicity of pING-hHER3FL

NCT03832855 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro00104093
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer

Keywords

Breast Cancer; Immunotherapy; HER2; HER3; T cell; vaccine

Outcome Measures

Primary Outcomes (1)

• Rate of T and B cell activity

  B cell and T cell specific immune response to pING-hHER3FL vaccinationvaccination

  12 months

Secondary Outcomes (2)

• Tolerability of pING-hHER3FL

  12 weeks

• Relapse-free survival

  5 years

Study Arms (1)

Treatment

EXPERIMENTAL

4 mg pING-hHER3FL ID or IM

Biological: pING-hHER3FL

Interventions

pING-hHER3FL BIOLOGICAL

Plasmid vaccine containing HER3

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of solid tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data in the literature). Demonstration of HER3 expression is not required for enrollment.
• Has undergone surgical resection of malignancy and has completed intended standard course of chemotherapy and HER2 targeted therapy and radiotherapy under the direction of their physician. Subjects may continue on adjuvant hormonal therapy.
• Has no evidence of disease by standard imaging studies (performed at the direction of their physician) within 60 days prior to initiating study treatment.
• Between 3 weeks and 2 years since prior cytotoxic chemotherapy, HER2-targeted therapy or radiotherapy to the start of study treatment.
• ECOG 0 or 1
• Estimated life expectancy \> 3 months.
• Age ≥ 18 years.
• Adequate hematologic function, with ANC \>1500/µL, Hemoglobin ≥ 9 g/dL, and Platelets ≥ 75,000/µL.
• Adequate renal and hepatic function, with Serum Creatinine \< 1.5 mg/dL, Bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x ULN or if liver metastases are present \< 5 x ULN.
• Female patients must be of non-child-bearing potential or use effective contraception, .
• Labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the start of study treatment.
• Ability to understand and provide signed informed consent.
• Ability to return to the study site for adequate follow-up, as required by this protocol.
• Negative serum pregnancy test within 7 days prior to the start of study treatment, for women of childbearing potential only.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herbert Lyerly: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 6, 2019
• Study Start: July 13, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)