Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer
Public ClinicalTrials.gov record NCT07652242. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT07652242
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Immunomic Therapeutics, Inc.
- Industry
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- ITI-5000 mRNA Vaccine Biological
- Pembrolizumab Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jul 31, 2028
- Last update posted
- Jul 22, 2026
2026 – 2028
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | 49546 | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07652242, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07652242 live on ClinicalTrials.gov.