Sponsor:
OncoNano Medicine, Inc.
Code:
NCT06022029
Conditions
Triple Negative Breast Cancer
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Lymphoma, Non-Hodgkin
Mantle Cell Lymphoma
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
ONM-501
Cemiplimab
Brief summary:
Conditions
Triple Negative Breast Cancer
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Lymphoma, Non-Hodgkin
Mantle Cell Lymphoma
Study ID
NCT06022029
Start date
Oct 13, 2023
Status verified date
Mar, 2025
Completion date
Aug 29, 2026
Anticipated
Primary completion date
Apr 30, 2026
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
168 participants
Anticipated
Allocation
Non randomized
Intervention Model
Sequential
Primary purpose
Treatment
Arms
experimental: Part 1a: Monotherapy Dose Escalation
experimental: Part 1b: ONM-501 in Combination with cemiplimab
experimental: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts
Interventions
ONM-501
Cemiplimab
Primary outcome measure
Central contacts
Locations
California Research Institute
Recruiting
Los Angeles, California, United States, 90027
Contacts
Clare Gregorio
cg@caresinst.comPrincipal Investigator:
Ghassan Al-Jazayrly, MD
Gabrail Cancer Center Research
Recruiting
Canton, Ohio, United States, 44718
Contacts
Principal Investigator:
Nashat Y Gabrail, MD
Ohio State University
Recruiting
Columbus, Ohio, United States, 43210
Contacts
Allison Reynolds
osuccclinicaltrials@osumc.eduPrincipal Investigator:
Joal Beane, MD
Allegheny Health Network
Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contacts
Principal Investigator:
Patrick Wagner, MD
UPMC Hillman Cancer Center
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contacts
Principal Investigator:
Julia Foldi, MD
University of Texas Southwestern Medical Center
Recruiting
Dallas, Texas, United States, 75390
Contacts
Principal Investigator:
Heather McArthur
MD Anderson Cancer Center
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Sarina A. Piha-Paul, MD
Virginia Cancer Specialists, PC
Recruiting
Fairfax, Virginia, United States, 22031
Contacts
Principal Investigator:
Alexander Spira, MD
Sponsor
OncoNano Medicine, Inc.
Last update posted
Mar 21, 2025
Last verified
Mar, 2025
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by OncoNano Medicine, Inc. on 2025-03-21.