Actively Recruiting
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
Led by OncoNano Medicine, Inc. · Updated on 2025-12-24
168
Participants Needed
16
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.
CONDITIONS
Official Title
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age 18 years or older
- Have advanced, nonresectable, or recurrent solid tumors or lymphomas confirmed by biopsy or pathology
- No standard therapy options available
- Have at least one injectable and measurable tumor lesion
- Prior Hepatitis B or C allowed if liver function is adequate
- HIV positive allowed if on stable treatment for at least 4 weeks, viral load under 400 copies/mL, and CD4+ count at least 350 cells/uL
- Adequate bone marrow function
- Adequate liver function
You will not qualify if you...
- Active other cancer within past 2 years except certain skin, bladder, cervical, or breast cancers treated with curative therapy
- Major surgery within 4 weeks before first study treatment
- Untreated brain metastases or metastases in posterior fossa or meninges; stable or treated brain metastases may be allowed case-by-case
- QTc interval longer than 470 ms with normal electrolytes
- Pregnant or breastfeeding females
- Females of childbearing potential not using effective contraception
- Uncontrolled high blood pressure
- Prior investigational therapy within 5 half-lives or 4 weeks before study drug
- Major cardiovascular event within 6 months prior to study drug
- Known allergy to ONM-501 components
- Active infection requiring systemic treatment
- Currently in another therapeutic clinical trial
- Known allergy to cemiplimab (for combination therapy)
- Active or recent autoimmune disease or recent corticosteroid use over 10 mg prednisone equivalent
- Need for systemic corticosteroid treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
California Research Institute
Los Angeles, California, United States, 90027
Active, Not Recruiting
2
BRCR Global
Tamarac, Florida, United States, 33321
Withdrawn
3
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Completed
4
Ohio State University
Columbus, Ohio, United States, 43210
Completed
5
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Completed
6
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Completed
7
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Completed
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
9
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Completed
10
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
11
Cancer Care Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
12
University of the Sunshine Coast Clinical Trials
Buderim, Queensland, Australia, 4556
Actively Recruiting
13
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
14
Princess Alexandra Hospital | Metro South Health
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
15
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Completed
16
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Active, Not Recruiting
Research Team
T
Trials@OncoNanoMed.com
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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