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

> **NCT07652242** · PHASE1 · RECRUITING · sponsor: **Immunomic Therapeutics, Inc.** · enrollment: 60 (estimated)

## Conditions studied

- Triple Negative Breast Cancer (TNBC)

## Interventions

- **BIOLOGICAL:** ITI-5000 mRNA Vaccine
- **DRUG:** Pembrolizumab
- **BIOLOGICAL:** ITI-5000 mRNA Vaccine
- **DRUG:** Olaparib
- **DRUG:** Capecitabine
- **BIOLOGICAL:** ITI-5000 MTD (Maximum Tolerated Dose)

## Key facts

- **NCT ID:** NCT07652242
- **Lead sponsor:** Immunomic Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-07-14
- **Primary completion:** 2028-02
- **Final completion:** 2028-08
- **Target enrollment:** 60 (ESTIMATED)
- **Last updated:** 2026-09-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07652242

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07652242, "Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07652242. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*