New RNA shot directly into tumors could boost immune attack

NCT ID NCT06249048

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called STX-001, a self-replicating RNA that makes a protein to stimulate the immune system. It is injected directly into tumors, either alone or with the immunotherapy pembrolizumab (Keytruda). The study aims to find a safe dose and see if it can shrink advanced solid tumors in about 108 adults.

What this could mean

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

Active substance

STX-001 (a self-replicating RNA that produces IL-12, injected directly into tumors) and pembrolizumab (Keytruda, an immunotherapy drug)

What this could lead to

If it works, this could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.

What could go wrong

This is an early first-in-human trial, so safety and effectiveness are not yet known. The treatment may cause side effects or fail to shrink tumors.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • HonorHealth Research and Innovation Institute

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85258, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Huntsman Cancer Institute - University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Melanoma Institute Australia

    RECRUITING

    Wollstonecraft, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • NextGen Oncology

    RECRUITING

    Beverly Hills, California, 90212, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••