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NCT04590326RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
612 (estimated)
First submitted
9 Oct 2020
Start date
8 Dec 2020
Primary completion date
8 Nov 2028
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT04590326
EU CT number
2022-501904-83-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 612
  • From 8 Dec 2020 to the primary completion date, 8 Nov 2028
  • 28 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
  • Prior treatment with a Mucin 16 (MUC16)-targeted therapy
  • Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
  • Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
  • Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

Other illness

  • Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
  • Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
  • Has history of clinically significant cardiovascular disease as defined in the protocol
  • Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
    • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Coordinator of this site? Confirm its status
BarretosBrazilRecruiting
Centro de Pesquisa em Oncologia PUCRS
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
AC Camargo Cancer Center, Fundacao Antonio Prudente
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Unimed Sorocaba
Coordinator of this site? Confirm its status
SorocabaBrazilRecruiting
Institut Català d'Oncologia
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GironaSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainRecruiting
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Francois Baclesse
Coordinator of this site? Confirm its status
Caen Cedex 5FranceRecruiting
Centr Georges Francois Leclerc
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Dana Farber Cancer Institute Brookline Avenue
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BostonUnited StatesRecruiting
University of Chicago Medical Center
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ChicagoUnited StatesRecruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
The Ohio State University -Wexner Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
City of Hope Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
The City of Hope Orange County Lennar Foundation Cancer Center
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Chao Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
Perelman School of Medicine at the University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Seattle Cancer Care Alliance at South Lake Union - G3630
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
H Lee Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.