RecruitingPhase 1NCT07652242

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)


Sponsor

Immunomic Therapeutics, Inc.

Enrollment

60 participants

Start Date

Jul 14, 2026

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ITI-5000 mRNA Vaccine, a biological treatment called ITI-5000 mRNA Vaccine, and others for people with triple negative breast cancer(tnbc). The study is currently recruiting participants at 2 locations.

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.

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Interventions

BIOLOGICALITI-5000 mRNA Vaccine

Participants receive ITI-5000. Cohort 1 will receive 1 ug of vaccine

DRUGPembrolizumab

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.

BIOLOGICALITI-5000 mRNA Vaccine

Participants receive ITI-5000. Cohort 2 will receive 10 ug of vaccine

DRUGOlaparib

Participants will receive Olaparib in combination with Pembrolizumab and ITI-5000

DRUGCapecitabine

Participants will receive Capecitabine in combination with Pembrolizumab and ITI-5000

BIOLOGICALITI-5000 MTD (Maximum Tolerated Dose)

Participants receive ITI-5000 Maximum Tolerated Dose (MTD)


Locations(2)

START Midwest

Grand Rapids, Michigan, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07652242


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