New Tumor-Injected drug shows promise in early cancer trial

NCT ID NCT06022029

Recruiting now Disease control Sponsor: OncoNano Medicine, Inc. Source: ClinicalTrials.gov ↗

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.

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.

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.

BLADDER CANCER CARCINOMA IN SITU CERVIX CANCER DIFFUSE LARGE B-CELL LYMPHOMA FOLLICULAR LYMPHOMA HEAD AND NECK SQUAMOUS CELL CARCINOMA LYMPHOMA, NON-HODGKIN MANTLE CELL LYMPHOMA METASTATIC CANCER SKIN CANCER TRIPLE NEGATIVE BREAST CANCER TUMOR RECURRENCE TUMOR, SOLID UVEAL MELANOMA, RECURRENT

Contacts and locations

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WITHDRAWN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
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
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
Tasman Oncology Research
RECRUITING

Southport, Queensland, 4215, Australia
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
Virginia Cancer Specialists, PC
COMPLETED

Fairfax, Virginia, 22031, United States

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