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A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug(s) are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Official title: A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-09-23
Completion Date
2030-02-03
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
REGN10597
Administered per the protocol
Cemiplimab
Administered per the protocol
Locations (11)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Yale School of Medicine
North Haven, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Start Midwest Cancer Research
Grand Rapids, Michigan, United States
Northwell Health
Lake Success, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
The Start Center for Cancer Care
San Antonio, Texas, United States