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
- Diseases
- Endometrial cancer, Ovarian cancer
- 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
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Centro de Pesquisa em Oncologia PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| AC Camargo Cancer Center, Fundacao Antonio Prudente Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Unimed Sorocaba Coordinator of this site? Confirm its status | Sorocaba | Brazil | Recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Dana Farber Cancer Institute Brookline Avenue Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| The City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Perelman School of Medicine at the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Seattle Cancer Care Alliance at South Lake Union - G3630 Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| H Lee Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.