A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab
Phase 1
168
about 2.9 years
18+
9 sites in CA, FL, OH +3
What this study is about
Researchers are testing different doses of a drug (ONM-501) given directly into tumors, alone or with another medication (Cemiplimab), to see what the highest dose that can be safely used, the lowest effective dose, or a recommended dose for expansion is in people with advanced solid tumors and lymphomas. The trial will last about 1051 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Cemiplimab
- 2.Take ONM-501
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cemiplimab
Primary: Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs), Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
Secondary: Dose Escalation and Expansion Phases: Cmax, Dose Escalation and Expansion Phases: Tmax, Expansion Phase Only: Duration of Response (DOR), Expansion Phase Only: Objective Response Rate (ORR), Expansion Phase Only: Overall Survival (OS), Expansion Phase Only: Progression-Free Survival (PFS)
Oncology