First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )

This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC). ITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines. The study has two parts: * Part A: Participants receive ITI

Trial Details

NCT ID
NCT07652242
Phase
PHASE1
Sponsor
Immunomic Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • ITI-5000 TNBC Vaccine
  • ITI-5000 TNBC Vaccine + Pembrolizumab
Locations (sample)
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Grand Rapids, Michigan, United States|42.96336,-85.66809

Key Eligibility Criteria

  • Age: Adults aged 18 years or over.
  • Consent: Provided a signed and dated informed consent form (ICF).
  • Diagnosis: Histologically confirmed stage 2-3 triple-negative breast cancer (TNBC), defined as HER2-negative, ER-negative, and PgR-negative by immu…
  • Prior Treatment: Completed all planned standard therapy (surgery, chemotherapy, radiation, and/or pembrolizumab as applicable) and be within 36 mon…

For full eligibility, visit ClinicalTrials.gov.

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