RecruitingPhase 1Phase 2NCT06413680

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

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

240 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase (first-in-human) study testing a new experimental cancer drug called REGN10597, alone or in combination with cemiplimab (an immunotherapy drug), in adults with advanced solid tumors (cancers that have spread in the body). The study is designed to find the safest and most effective dose. **You may be eligible if...** - You are an adult with a confirmed advanced or metastatic solid tumor cancer - Your cancer has continued to grow despite standard treatments - Depending on the study cohort, you may have specific cancer types including melanoma or kidney cancer that has progressed after immunotherapy - You are able and willing to undergo tumor biopsies **You may NOT be eligible if...** - You have not yet tried standard treatments for your cancer - You are unwilling or unable to have tumor biopsies - Your overall health or organ function does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN10597

Administered per the protocol

DRUGCemiplimab

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

View Full Details on ClinicalTrials.gov

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NCT06413680


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