A First-In Human (FIH) Trial of REGN10597 Medicine
Phase 1/2
240
about 5.4 years
18+
11 sites in CA, CT, IL +5
What this study is about
This trial is testing REGN10597 medicine alone or with cemiplimab in adults who have cancer that has spread. The goal is to see how safe, tolerable, and effective the medicine is. Researchers are also looking at potential side effects and how much of the medicine is in the body.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Cemiplimab
- 2.Take REGN10597
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: Incidence of Dose-Limiting Toxicities (DLTs), Incidence of Serious Adverse Events (SAEs), Incidence of TEAEs leading to death, Incidence of TEAEs leading to treatment discontinuation, Incidence of Treatment-Emergent Adverse Event (TEAEs), Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Secondary: Best Overall Response (BOR) based on RECIST 1.1 criteria, Disease control rate based on RECIST 1.1, Duration Of Response (DOR) based on RECIST 1.1 criteria, ORR based on RECIST 1.1 criteria by investigator assessment, Progression Free Survival (PFS) based on RECIST 1.1
Oncology