Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer

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

Breast Cancer

Interventions

ITI-5000 TNBC Vaccine
ITI-5000 TNBC Vaccine + Pembrolizumab

Locations (sample)

Grand Rapids, Michigan, United States|42.96336,-85.66809
Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study.
Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surg…
Applicable to Part B only. Participant is currently receiving or is planned to receive standard of care adjuvant therapy, including pembrolizumab i…
Adults aged 18 years or over.

For full eligibility, visit ClinicalTrials.gov.

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