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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
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
REGN5668
Administer per the protocol
Cemiplimab
Administer per the protocol
Ubamatamab
Administer per the protocol
Sarilumab
Administer per the protocol
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