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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2023
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to understand and willingness to sign written informed consent before performance of any study procedures 2. Age ≥ 18 years 3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists. 4. Participants must have a minimum of one injectable and measurable lesion. 5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function 6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load \<400 copies/mL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL 7. Adequate bone marrow function: 8. Adequate liver function Exclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b). 1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy. 2. Major surgery within 4 weeks before the first dose of study drug. 3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion. 4. Prolongation of corrected QT (QTc) interval to \>470 millisecond (ms) for males and females when electrolytes balance is normal. 5. Females who are breastfeeding or pregnant at screening or baseline 6. Females of childbearing potential that refuse to use a highly effective method of contraception. 7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP \> 9. Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter. 8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501 9. Has an active infection requiring systemic treatment 10. Is participating in another therapeutic clinical trial Additional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b) 1. Has known hypersensitivity to any component in the formulation of cemiplimab 2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily prednisone equivalent) 3. Has a condition requiring systemic treatment with corticosteroids
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Allegheny Health Network
COMPLETEDPittsburgh, Pennsylvania, 15224, United States
-
BRCR Global
WITHDRAWNTamarac, Florida, 33321, United States
-
California Research Institute
ACTIVE_NOT_RECRUITINGLos Angeles, California, 90027, United States
-
Cancer Care Wollongong
RECRUITINGWollongong, New South Wales, 2500, Australia
-
Gabrail Cancer Center Research
COMPLETEDCanton, Ohio, 44718, United States
-
MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
-
Ohio State University
COMPLETEDColumbus, Ohio, 43210, United States
-
Princess Alexandra Hospital | Metro South Health
RECRUITINGWoolloongabba, Queensland, 4102, Australia
-
Southern Oncology Clinical Research Unit
COMPLETEDBedford Park, South Australia, Australia
-
St John of God Subiaco Hospital
ACTIVE_NOT_RECRUITINGSubiaco, Western Australia, 6008, Australia
-
St Vincent's Hospital
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
-
Tasman Oncology Research
RECRUITINGSouthport, Queensland, 4215, Australia
-
UPMC Hillman Cancer Center
COMPLETEDPittsburgh, Pennsylvania, 15232, United States
-
University of Texas Southwestern Medical Center
COMPLETEDDallas, Texas, 75390, United States
-
University of the Sunshine Coast Clinical Trials
RECRUITINGBuderim, Queensland, 4556, Australia
-
Virginia Cancer Specialists, PC
COMPLETEDFairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria may hold clues to why some cancer treatments work better
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can immunotherapy before surgery stop early oral cancer from returning?
- Can a glowing dye show surgeons where head and neck tumors end?
- Unlocking TNBC survival: genetic clues from 3,648 women