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RECRUITING
NCT06413680
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

REGN10597

Administered per the protocol

DRUG

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