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.
NCT ID: NCT06022029
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
168 participants
INTERVENTIONAL
2023-10-13
2026-08-29
Brief Summary
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Detailed Description
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The combination agent will be administered according to standard protocol, once every three weeks. This phase will evaluate ONM-501 in combination with approved immune checkpoint inhibitor (ICI) cemiplimab. Enrollment in this phase will follow a "Rolling 6" or 6+0 methodology - up to 6 patients will be enrolled in a staggered format; dose escalation of ONM-501 will be permitted.
Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of this study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a: Monotherapy Dose Escalation
ONM-501 will be administered as intratumoral injections once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days.
ONM-501
Intratumoral injection
Part 1b: ONM-501 in Combination with cemiplimab
ONM-501 will be administered as intratumoral injections once per week for three weeks followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days. The combination agent will be administered according to standard protocol, once every three weeks.
ONM-501
Intratumoral injection
Cemiplimab
Intravenous administration of 350 mg
Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts
Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of the study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.
ONM-501
Intratumoral injection
Cemiplimab
Intravenous administration of 350 mg
Interventions
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ONM-501
Intratumoral injection
Cemiplimab
Intravenous administration of 350 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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OncoNano Medicine, Inc.
INDUSTRY
Responsible Party
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Locations
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California Research Institute
Los Angeles, California, United States
BRCR Global
Tamarac, Florida, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
University of the Sunshine Coast Clinical Trials
Buderim, Queensland, Australia
Tasman Oncology Research
Southport, Queensland, Australia
Princess Alexandra Hospital | Metro South Health
Woolloongabba, Queensland, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Jia (Jenny) Liu, MD
Role: primary
Sue Parker
Role: primary
Hong Shue, MD
Role: primary
Nicole Tasker, PhD
Role: primary
Rahul Ladwa, MD
Role: primary
Other Identifiers
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ON-5001
Identifier Type: -
Identifier Source: org_study_id