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.
Start Date
10/13/2023
Completion Date
8/29/2026
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.
Detailed Description
This Phase 1, multi-center trial will consist of three parts: monotherapy dose escalation; combination therapy dose finding; and combination therapy dose expansion exploring two doses in specific tumor indication(s). Each dosing cycle of ONM-501 will be 21 days. ONM 501 will be administered as intratumoral injections once per week for three weeks (on Days 1, 8, and 15), followed by three weeks without ONM-501 administration. The monotherapy dose escalation will utilize an accelerated titration method. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ONM-501
Cemiplimab
Conditions
Locations
California Research Institute
Los Angeles, California 90027
United States
BRCR Global
Tamarac, Florida 33321
United States
Gabrail Cancer Center Research
Canton, Ohio 44718
United States
Ohio State University
Columbus, Ohio 43210
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
St Vincent's Hospital
Darlinghurst, New South Wales 2010
Australia
Cancer Care Wollongong
Wollongong, New South Wales 2500
Australia
University of the Sunshine Coast Clinical Trials
Buderim, Queensland 4556
Australia
Tasman Oncology Research
Southport, Queensland 4215
Australia
Princess Alexandra Hospital | Metro South Health
Woolloongabba, Queensland 4102
Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia
Australia
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
Australia