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Recruiting

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

NCT04590326 · Regeneron Pharmaceuticals
In plain English

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Official title
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
About this study
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
Eligibility criteria
Key Inclusion Criteria: 1. 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 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol. 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts) 4. Has adequate organ and bone marrow function as defined in the protocol 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has a life expectancy of at least 3 months 7. 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 Key Exclusion Criteria: 1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy 2. 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 3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy 4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy 5. 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 6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol 7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 8. Has history of clinically significant cardiovascular disease as defined in the protocol 9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s). Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study design
Enrollment target: 612 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-12-08
Estimated completion: 2027-11-30
Last updated: 2025-11-21
Interventions
Drug: REGN5668Drug: CemiplimabDrug: UbamatamabDrug: SarilumabDrug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Primary outcomes
  • Incidence of Dose Limiting Toxicities (DLT) (42 days)
  • Incidence of DLTs (21 days post combination administration)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) (Through study completion, up to 5 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (24)
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
The City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Irvine, California, United States
Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
H. Lee Moffitt Cancer CenterCompleted
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer Institute Brookline AvenueRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Perelman School of Medicine at the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Seattle Cancer Care Alliance at South Lake Union - G3630Recruiting
Seattle, Washington, United States
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Vlaams-Brabant, Belgium
Hopital Lyon SudRecruiting
Pierre-Bénite, Auvergne-Rhône, France
Centre Georges Francois LeclercRecruiting
Dijon, Bourgogne-Franche-Comté, France
Institut BergonieRecruiting
Bordeaux, New Aquitaine, France
Centre Francois Baclesse (CFB)Recruiting
Caen, Normandy, France
Institut Gustave RoussyRecruiting
Villejuif, France
Hospital Clinico Universitario Santiago de CompostelaRecruiting
Santiago de Compostela, A Coruna, Spain
Institut Catala dOncologia GironaRecruiting
Girona, Spain
Ciudad UniversitariaRecruiting
Madrid, Spain
Hospital Universitario Fundacion JimenezRecruiting
Madrid, Spain
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCMRecruiting
Madrid, Spain
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 · TrialPath