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

NCT07652242 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

BIOLOGICAL

ITI-5000 mRNA Vaccine

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

DRUG

Pembrolizumab

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.

BIOLOGICAL

ITI-5000 mRNA Vaccine

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

DRUG

Olaparib

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

DRUG

Capecitabine

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

BIOLOGICAL

ITI-5000 MTD (Maximum Tolerated Dose)

Participants receive ITI-5000 Maximum Tolerated Dose (MTD)

Sponsors & Collaborators

  • Immunomic Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-02-29
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07652242 on ClinicalTrials.gov