Testing a new cancer vaccine for advanced cancers

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

This study is testing a new cancer vaccine to see if it can help people with advanced cancers by boosting their immune response against a specific protein.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT03832855 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial evaluates the safety and tolerability of an investigational cancer vaccine called pING-hHER3FL, which targets the HER3 protein overexpressed in various malignancies. The vaccine is designed to induce immune responses against HER3, potentially preventing the emergence of resistant cancer cells. Participants must have undergone surgical resection of their solid tumors and completed standard treatments. The study aims to assess whether immunization can elicit a HER3-specific immune response in patients with advanced cancer.

Who should consider this trial

Good fit: Ideal candidates include patients with a documented history of solid tumors expressing HER3 who have undergone surgical resection and completed standard treatments.

Not a fit: Patients with active disease or those who have not completed their standard treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new immunotherapy option for patients with advanced cancers that express HER3.

How similar studies have performed: Other studies have shown promise with immunotherapies targeting HER family receptors, suggesting potential for success with this novel approach.

Eligibility criteria

Inclusion 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.

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

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Michael Morse, MD

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