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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: Recruiting Phase 1 study, sponsored by Immunomic Therapeutics.
NCT07652242 is a Phase 1 study that is actively recruiting participants, run by Immunomic Therapeutics. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07652242 shows while recruiting
NCT07652242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT07652242 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07652242's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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