Clinical Trials /

Mutant Kirsten Rat Sarcoma (KRAS) -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

NCT05013216

Description:

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Mutant Kirsten Rat Sarcoma (KRAS) -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
  • Official Title: Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: J2177
  • SECONDARY ID: IRB00288752
  • NCT ID: NCT05013216

Conditions

  • High Risk Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
KRAS peptide vaccineHiltonol® (Poly-ICLC)KRAS peptide vaccine

Purpose

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.

Trial Arms

NameTypeDescriptionInterventions
KRAS peptide vaccineExperimental
  • KRAS peptide vaccine

Eligibility Criteria

        Inclusion Criteria:

        Must fall into one of the three categories defined as high risk of developing pancreatic
        cancer:

          -  High Risk Group 1 (familial pancreatic cancer relatives):

               -  older than 55 years old or 10 years younger than the age of youngest relative
                  with pancreatic cancer, and

               -  Have 2 or more family members with a history of pancreatic cancer, and

               -  Have a first-degree relationship with at least one of the relatives with
                  pancreatic cancer.

          -  High Risk Group 2 (Has gene mutation(s) with an associated with an estimated lifetime
             risk of pancreatic cancer of approximately 10% or higher):

               -  50 years old and has FAMMM (p16/CDKN2A) gene mutation.

               -  older than 50 years old or 10 years younger than the age of the youngest relative
                  with pancreatic cancer, and

               -  Has known BRCA2, Acute Transverse Myelopathy (ATM), partner and localizer of
                  BRCA2 (PALB2) gene mutation, and

               -  There is more than 1 pancreatic cancer in the family, one of whom is a first- or
                  second-degree relative of the subject to be screened.

          -  High Risk Group 3 (Has gene mutation(s) with an associated with an estimated lifetime
             risk of pancreatic cancer of approximately 5%):

               -  Older than 55 years old or 10 years younger than the age of the youngest relative
                  with pancreatic cancer, and

               -  Has known BRCA1, or HNPCC (hereditary non-polyposis colorectal cancer or Lynch
                  syndrome, hMLH1, hMSH2, postmeiotic segregation 1(PMS1), human MutS homolog 6
                  (hMSH6), EpCAM) gene mutations, and

               -  There is more than 1 pancreatic cancer in the family, one of whom is a first- or
                  second-degree relative of the subject to be screened.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Patients must have adequate organ and marrow function defined by study-specified
             laboratory tests prior to initial study drug.

          -  Ability to understand and willingness to sign a written informed consent document.

          -  Woman of childbearing potential must have a negative pregnancy test and follow
             contraceptive guidelines as defined per protocol.

          -  Men must use acceptable form of birth control while on study.

        Exclusion Criteria:

          -  If expected to require any other form of systemic or localized antineoplastic therapy
             while on study.

          -  Within 4 weeks prior to first dose of study drug.

             o Any systemic or topical corticosteroids at immunosuppressive agents.

          -  Within 4 weeks prior to first dose of study drug.

               -  Any investigational device.

               -  Has received a live vaccine.

               -  Received any allergen hyposensitization therapy.

               -  Any major surgery.

          -  Infection with HIV or hepatitis B or C.

          -  Uncontrolled intercurrent illness including, but not limited to, uncontrolled
             infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia,
             metastatic cancer, or psychiatric illness/social situations that would limit
             compliance with study requirements monoclonal antibody.

          -  Has a diagnosis of immunodeficiency.

          -  Any other sound medical, psychiatric, and/or social reason as determined by the
             Investigator.

          -  Unwilling or unable to follow the study schedule for any reason.

          -  Are pregnant or breastfeeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:50 Years
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Number of participants experiencing study drug-related toxicities
Time Frame:24 months
Safety Issue:
Description:Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0

Secondary Outcome Measures

Measure:Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 T cells
Time Frame:Baseline and 4 years
Safety Issue:
Description:Maximal percent change of IFN-g prod mutant KRAS specific CD8 T cells at any time after vaccination compared to the pre-vaccination baseline.
Measure:Maximal percentage of change of IFN-γ-producing mutant-KRAS-specific CD4 T cells
Time Frame:Baseline and 4 years
Safety Issue:
Description:Maximal percent change of IFN-g prod mutant KRAS specific CD4 T cells at any time after vaccination compared to the pre-vaccination baseline.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • KRAS Peptide Vaccine
  • Neoantigen Vaccines
  • Cancer Vaccines
  • Immunotherapy
  • Pancreatic Ductal Adenocarcinoma (PDAC)

Last Updated

August 19, 2021