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RECRUITING
NCT04590326
PHASE1/PHASE2

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer

Official title: A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

612

Start Date

2020-12-08

Completion Date

2027-11-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

REGN5668

Administer per the protocol

DRUG

Cemiplimab

Administer per the protocol

DRUG

Ubamatamab

Administer per the protocol

DRUG

Sarilumab

Administer per the protocol

DRUG

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

Administer per the protocol

Locations (24)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Seattle Cancer Care Alliance at South Lake Union - G3630

Seattle, Washington, United States

Universitair Ziekenhuis Leuven

Leuven, Vlaams-Brabant, Belgium

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône, France

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France

Centre Francois Baclesse (CFB)

Caen, Normandy, France

Institut Bergonie

Bordeaux, Nouvelle-Aquitaine, France

Institut Gustave Roussy

Villejuif, France

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

Institut Catala dOncologia Girona

Girona, Spain

Ciudad Universitaria

Madrid, Spain

Hospital Universitario Fundacion Jimenez

Madrid, Spain

Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

Madrid, Spain