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Clinical Trials in the USA / NCT06022029
Recruiting Phase 1

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.

NCT06022029 · tracked via the Priya Life Science USA tracker
Sponsor
OncoNano Medicine, Inc.
Phase
Phase 1
Started
2023-10-13
Last updated
2025-12-24

Condition(s) studied

Triple Negative Breast CancerDiffuse Large B Cell LymphomaFollicular LymphomaLymphoma, Non-HodgkinMantle Cell LymphomaBladder CancerUveal Melanoma, RecurrentCervix CancerCarcinoma in SituHead and Neck Squamous Cell CarcinomaSkin CancerMetastatic CancerTumor, SolidTumor Recurrence

Investigational drug(s) / intervention(s)

ONM-501Cemiplimab

ONM-501: Intratumoral injection

Cemiplimab: Intravenous administration of 350 mg

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
California Research Institute Los Angeles California Active Not Recruiting
BRCR Global Tamarac Florida Withdrawn
Gabrail Cancer Center Research Canton Ohio Completed
Ohio State University Columbus Ohio Completed
Allegheny Health Network Pittsburgh Pennsylvania Completed
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Completed
University of Texas Southwestern Medical Center Dallas Texas Completed
MD Anderson Cancer Center Houston Texas Active Not Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia Completed
St Vincent's Hospital Darlinghurst New South Wales Recruiting
Cancer Care Wollongong Wollongong New South Wales Recruiting
University of the Sunshine Coast Clinical Trials Buderim Queensland Recruiting
Tasman Oncology Research Southport Queensland Recruiting
Princess Alexandra Hospital | Metro South Health Woolloongabba Queensland Recruiting
Southern Oncology Clinical Research Unit Bedford Park South Australia Completed
St John of God Subiaco Hospital Subiaco Western Australia Active Not Recruiting

On this site

📄 Libtayo (cemiplimab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06022029 on ClinicalTrials.gov ↗ ← All trials in the USA