Actively Recruiting
A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Alone or With Cemiplimab in Patients With Recurrent Ovarian or Other MUC16+ Cancers
Led by Regeneron Pharmaceuticals · Updated on 2026-05-08
890
Participants Needed
52
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of ubamatamab, alone or combined with cemiplimab, in women with recurrent ovarian cancer or uterine cancer expressing MUC16. The study also examines how these drugs behave in the body and their potential to treat advanced recurrent disease, focusing on preventing or reducing Cytokine Release Syndrome (CRS). This trial is a Phase 1/2 study sponsored by Regeneron Pharmaceuticals. Participants receive ubamatamab either by itself or together with cemiplimab. The study includes dose escalation and non-randomized dose expansion phases. Some patients may receive pretreatment to help prevent or lessen CRS. Treatments are given according to the protocol, and researchers monitor the participants closely during the study period. During the trial, participants undergo various assessments including measuring drug levels in the blood, monitoring for side effects and adverse events, and evaluating tumor response using criteria like RECIST 1.1. Quality of life, physical functioning, and ovarian symptoms are also tracked through questionnaires up to two years. Safety is monitored throughout and participants are followed for signs of effectiveness and tolerability over this period.
CONDITIONS
Brief Title
Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with confirmed advanced epithelial ovarian cancer (excluding carcinosarcoma), primary peritoneal, or fallopian tube cancer with serum CA-125 level ≥2 times upper limit of normal (except low-grade serous carcinoma)
- Received at least one line of platinum-containing therapy or are platinum-intolerant
- Documented relapse or progression after the most recent therapy
- No standard therapies likely to provide clinical benefit
- Adequate organ and bone marrow function per protocol
- Life expectancy of at least 3 months
- For phase 2 expansion: platinum-resistant ovarian cancer with 2 to 4 prior lines of platinum-based therapy
- Endometrial cancer patients with confirmed progression after prior PD-1 therapy and platinum chemotherapy
- Tumor cells positive for MUC16 in at least 25% by immunohistochemistry
- Have had 1 to 4 prior lines of systemic therapy as described in the protocol
You will not qualify if you...
- Prior treatment with anti-PD-1 or PD-L1 therapy as defined in the protocol
- More than 4 prior lines of cytotoxic chemotherapy (except for low-grade serous ovarian cancer cohort)
- Prior treatment with any MUC16-targeted therapy
- Untreated or active primary brain tumor, CNS metastases, or spinal cord compression
- History or current cardiovascular disease as defined in the protocol
- Severe or uncontrolled hypertension; must be on stable anti-hypertensive medication if treated
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive treatment with REGN4018 (Ubamatamab) alone or in combination with cemiplimab according to the study protocol.
Visits occur regularly during treatment as per protocol for drug administration and monitoring
Duration - Up to 2 years
Participants are monitored for safety, treatment-emergent adverse events, and long-term outcomes after treatment ends.
Periodic visits for assessments and monitoring
Trial Site Locations
Total: 52 locations
1
University of Alabama_6th Ave
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55901
Actively Recruiting
5
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Withdrawn
6
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, Ohio, United States, 43026
Actively Recruiting
9
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
12
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Completed
13
Peter MacCallum Cancer Center
Melbourne, Australia, 3000
Completed
14
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
15
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium, 6000
Actively Recruiting
16
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
17
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France, 69310
Actively Recruiting
18
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21000
Actively Recruiting
19
Institut Bergonie
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
20
Centre Francois Baclesse (CFB)
Caen, Normandy, France, 14076
Actively Recruiting
21
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France, 06189
Actively Recruiting
22
Institut Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
23
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
24
Sharet Institute of Oncology
Jerusalem, Israel, 9112001
Actively Recruiting
25
Sheba Medical Center
Tel Litwinsky, Israel, 5265601
Actively Recruiting
26
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
27
Humanitas S. Pio X
Milan, Italy, 20159
Actively Recruiting
28
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
29
Instituto Nazionale Tumori- Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
30
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB
Actively Recruiting
31
Erasmus MC
Rotterdam, South Holland, Netherlands, 3000 DR
Actively Recruiting
32
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
33
Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
34
Asan Medical Center, Univ. of Ulsan
Seoul, South Korea, 05505
Actively Recruiting
35
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
36
Korea University Guro Hospital
Seoul, South Korea, 08307
Actively Recruiting
37
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
38
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
39
Institut Catala dOncologia Badalona
Badalona, Spain, 08916
Actively Recruiting
40
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
41
Institut Catala d'Oncologia
Barcelona, Spain, 8908
Actively Recruiting
42
Clinica Universidad Navarra (CUN) Madrid
Madrid, Spain, 28027
Actively Recruiting
43
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
44
Hospital Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
45
Hospital Clinico Universitatio Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
46
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX1 2JD
Actively Recruiting
47
Royal Marsden Hospital - Sutton
Sutton, Surrey, United Kingdom, SM2 5PT
Withdrawn
48
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
49
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
50
Guys Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
51
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
52
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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