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Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

NCT05013216 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-03

No results posted yet for this study

Summary

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.

Conditions

Interventions

DRUG

Cohort A: Patients at high risk of developing pancreatic cancer.

1. KRAS peptide vaccine with poly-ICLC adjuvant will be administered on Prime week 1, 3, and 5. Boost vaccinations with will be administered at week 13. All subjects will return to the study site approximately 28 days (+ 7 days) after the last vaccination for an End of Treatment (EOT) and safety evaluation. 2. Drug: up to 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC

DRUG

Cohort B: Patients must have evidence of a pancreatic cystic neoplasm

Patients will receive KRAS peptide vaccine with poly-ICLC adjuvant as two prime vaccinations on weeks 1 and 2. Surgery is considered standard of care. Surgery will occur at the discretion of the treating hepatobiliary surgeon and is not dictated by this protocol. Subjects will return to the study site approximately at week 4 (+ 7 days) for a safety evaluation prior to surgery. Subjects will have an End of Treatment (EOT) visit at study Week 8 (+ 7 days).

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nilofer Azad, MD · Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2027-10-01
Completion
2031-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013216 on ClinicalTrials.gov