Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer
A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)
Immunomic Therapeutics, Inc.
60 participants
Jul 14, 2026
INTERVENTIONAL
Conditions
Summary
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-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose. * Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants receive ITI-5000. Cohort 1 will receive 1 ug of vaccine
Participants will receive ITI-5000 as an intramuscular injection every 21 days for 3 doses. Participants will also receive pembrolizumab as per the FDA-approved package insert.
Participants receive ITI-5000. Cohort 2 will receive 10 ug of vaccine
Participants will receive Olaparib in combination with Pembrolizumab and ITI-5000
Participants will receive Capecitabine in combination with Pembrolizumab and ITI-5000
Participants receive ITI-5000 Maximum Tolerated Dose (MTD)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07652242