Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific) Administered in Combination With Cemiplimab or REGN4018 (MUC16xCD3)

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is researching an investigational drug called REGN5668. Participants will receive additional investigational drugs in combination with REGN5668. These additional drugs include cemiplimab or 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) 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 or REGN4018 * How REGN5668 works in the body either alone and/or in combination with cemiplimab or REGN4018 * How much of the study drugs (REGN5668, cemiplimab, REGN4018) are in the blood * To see if REGN5668 in combination with cemiplimab or REGN4018 works to treat cancer * To find out how safe, tolerable, and effective in mitigating Cytokine Release Syndrome (CRS) sarilumab pretreatment is when given before REGN4018

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol

• Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.

• Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)

• Has adequate organ and bone marrow function as defined in the protocol

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Has a life expectancy of at least 3 months

• Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol

Locations
United States
California
City of Hope Comprehensive Cancer Center
RECRUITING
Duarte
The City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Florida
H. Lee Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute Brookline Avenue
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
Perelman School of Medicine at the University of Pennsylvania
RECRUITING
Philadelphia
Washington
Seattle Cancer Care Alliance at South Lake Union - G3630
RECRUITING
Seattle
Other Locations
Belgium
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Francois Baclesse (CFB)
RECRUITING
Caen
Centre Georges Francois Leclerc
RECRUITING
Dijon
Hopital Lyon Sud
RECRUITING
Pierre-benite
Spain
Institut Catala dOncologia Girona
RECRUITING
Girona
Ciudad Universitaria
RECRUITING
Madrid
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez
RECRUITING
Madrid
Hospital Clinico Universitario Santiago de Compostela
RECRUITING
Santiago De Compostela
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2020-12-09
Estimated Completion Date: 2027-04-27
Participants
Target number of participants: 612
Treatments
Experimental: Module 1
REGN5668 and cemiplimab
Experimental: Module 2
REGN5668 and REGN4018
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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