ACTIVE_NOT_RECRUITING

Assessing the Immunogenicity of pING-hHER3FL

Conditions

Advanced Cancer Breast Cancer Immunotherapy HER2 HER3 T cell vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-07-13

Study Completion:2030-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03832855

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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

Inclusion Criteria

Exclusion Criteria

* 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.

* 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

Contacts and Locations

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Herbert Lyerly

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-13

Study Completion Date2030-03

Study Record Updates

Study Start Date2020-07-13

Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Immunotherapy
HER2
HER3
T cell
vaccine

Additional Relevant MeSH Terms

Advanced Cancer