New Tumor-Injected drug shows promise in early cancer trial

NCT ID NCT06022029

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called ONM-501, which is injected directly into tumors, either alone or with the immunotherapy cemiplimab (Libtayo). The study includes 168 adults with advanced solid tumors or lymphomas that have not responded to standard treatments. The main goal is to find the safest and most effective dose.

What this could mean

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

Active substance

ONM-501 (injected into tumors) and cemiplimab (Libtayo, given intravenously)

What this could lead to

If successful, this could point toward a new treatment option for advanced cancers that have not responded to other therapies.

What could go wrong

This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The approach is experimental and may not work for all patients.

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.

Bites and Stings breast neoplasm cervical carcinoma diffuse large B-cell lymphoma follicular lymphoma head and neck squamous cell carcinoma in situ carcinoma lymphoma lymphoma, non-Hodgkin, familial mantle cell lymphoma melanoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-Hodgkin lymphoma Recurrence skin cancer skin neoplasm Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms uveal melanoma

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

  • Allegheny Health Network

    COMPLETED

    Pittsburgh, Pennsylvania, 15224, United States

  • BRCR Global

    WITHDRAWN

    Tamarac, Florida, 33321, United States

  • California Research Institute

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90027, United States

  • Cancer Care Wollongong

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

    Contact

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

  • Gabrail Cancer Center Research

    COMPLETED

    Canton, Ohio, 44718, United States

  • MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Ohio State University

    COMPLETED

    Columbus, Ohio, 43210, United States

  • Princess Alexandra Hospital | Metro South Health

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

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

    Contact

  • Southern Oncology Clinical Research Unit

    COMPLETED

    Bedford Park, South Australia, Australia

  • St John of God Subiaco Hospital

    ACTIVE_NOT_RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • St Vincent's Hospital

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

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

    Contact

  • Tasman Oncology Research

    RECRUITING

    Southport, Queensland, 4215, Australia

    Contact

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

  • UPMC Hillman Cancer Center

    COMPLETED

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    COMPLETED

    Dallas, Texas, 75390, United States

  • University of the Sunshine Coast Clinical Trials

    RECRUITING

    Buderim, Queensland, 4556, Australia

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

    Contact

  • Virginia Cancer Specialists, PC

    COMPLETED

    Fairfax, Virginia, 22031, United States