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NCT07652242 · ClinicalTrials.gov registry record · Phase 1
First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )
A Phase 1 study, sponsored by Immunomic Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07652242 is a Phase 1 study that is actively recruiting participants, run by Immunomic Therapeutics. The registered enrollment target is 60 participants.
The verdict
NCT07652242, a Phase 1 study, is actively recruiting participants, sponsored by Immunomic Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
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 an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL ITI-5000 mRNA Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07652242
The ClinicalTrials.gov registry entry for NCT07652242 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunomic Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT07652242 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07652242 about?
NCT07652242 is a clinical study titled "First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )". 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...
What is the current status of trial NCT07652242?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-06. Estimated completion is 2028-08.
What interventions are being tested in trial NCT07652242?
The interventions under investigation include: Pembrolizumab (DRUG), ITI-5000 mRNA Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07652242?
This trial is sponsored by Immunomic Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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