New RNA vaccine aims to stop breast cancer return

NCT ID NCT07652242

Recruiting now Disease control Sponsor: Immunomic Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 8 times

Summary

This early-stage trial tests an investigational cancer vaccine called ITI-5000 in 60 people with stage II-III triple-negative breast cancer who have finished standard treatment. The vaccine uses self-amplifying RNA to teach the immune system to attack cancer cells. The study first finds a safe dose of the vaccine alone, then tests it combined with the immunotherapy drug pembrolizumab.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ITI-5000 (self-amplifying RNA vaccine) and pembrolizumab
What this could lead to: If successful, this could lead to a new treatment option to prevent triple-negative breast cancer from coming back after standard therapy.
What could go wrong: This is a very early Phase 1 trial with only 60 participants, so it is too soon to know if the vaccine works. There may be side effects from the vaccine or the combination with pembrolizumab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TRIPLE-NEGATIVE BREAST CANCER (TNBC)

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

START Midwest
RECRUITING

Grand Rapids, Michigan, 49546, United States

Contact Email: •••••@•••••
Sarah Cannon Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States

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