Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

May 19, 2026 updated by: Regeneron Pharmaceuticals

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer.

The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin [PLD]), referred to as "combination drugs'.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug and its experimental combinations
  • How much study drug and fianlimab is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1J 0J9
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Research Institute - McGill University Health Centre
  • South Korea
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 8308
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center, Univ. of Ulsan
      • Seoul, South Korea, 135-720
        • Recruiting
        • Gangnam Severance Hospital
    • Gyeonggi-do
      • Gyeonggi-do, Gyeonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
    • Seoul
      • Incheon, Seoul, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
  • Taiwan
      • Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Municipal Wan Fang Hospital
      • Taipei, Taiwan, 114202
        • Recruiting
        • Tri-Service General Hospital
      • Taipei, Taiwan, 11211
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Hospital
    • Changhua City
      • Changhua, Changhua City, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01123
        • Recruiting
        • Baskent University
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
      • Ankara, Turkey (Türkiye), 0906520
        • Recruiting
        • Memorial Ankara Hospital
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Ankara Bilkent City Hospital
      • Istanbul, Turkey (Türkiye), 34450
        • Recruiting
        • Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa
      • Izmir, Turkey (Türkiye), 35575
        • Recruiting
        • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)
      • Sakarya, Turkey (Türkiye), 54290
        • Recruiting
        • Sakarya University - Education and Research Hospital
    • Adana
      • Seyhan, Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Medicalpark Seyhan Hospital
    • Ankara
      • Altındağ, Ankara, Turkey (Türkiye), 06240
        • Recruiting
        • Hacettepe University
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34284
        • Recruiting
        • Medipol University Hospital
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey (Türkiye), 27584
        • Recruiting
        • Gaziantep Medicalpoint Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The University of Alabama at Birmingham
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health Cancer Institute
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute, St. Matthews Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital of Allegheny Health Network
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center, Magee-Womens Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute Sioux Falls
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
  2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate organ and bone marrow function, as described in the protocol
  5. Platinum-Resistant Ovarian Cancer, as described in the protocol

Key Exclusion Criteria:

  1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
  2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
  3. Another malignancy that is progressing or requires active treatment, as described in the protocol
  4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
  5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
  6. Moderate to large or ascites, as described in the protocol
  7. Bowel obstruction within last 3 months or current need for parenteral nutrition

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm B
Drug: Ubamatamab
Administered per the protocol
Other Names:
  • REGN4018
Drug: Bevacizumab
Administered per the protocol
Other Names:
  • Avastin®
Drug: Sarilumab
Administered per the protocol
Other Names:
  • SAR153191
  • Kevzara®
  • REGN88
Experimental: Arm C
Drug: Cemiplimab
Administered per the protocol
Other Names:
  • REGN2810
  • Libtayo®
Drug: Ubamatamab
Administered per the protocol
Other Names:
  • REGN4018
Drug: Fianlimab
Administered per the protocol
Other Names:
  • REGN3767
Drug: Sarilumab
Administered per the protocol
Other Names:
  • SAR153191
  • Kevzara®
  • REGN88
Experimental: Arm D
Drug: Ubamatamab
Administered per the protocol
Other Names:
  • REGN4018
Drug: PLD
Administered per the protocol
Other Names:
  • Doxil®
  • Pegylated liposomal doxorubicin
Drug: Sarilumab
Administered per the protocol
Other Names:
  • SAR153191
  • Kevzara®
  • REGN88
Experimental: Arm A1
Drug: Ubamatamab
Administered per the protocol
Other Names:
  • REGN4018
Drug: Sarilumab
Administered per the protocol
Other Names:
  • SAR153191
  • Kevzara®
  • REGN88
Experimental: Arm A2
Drug: Ubamatamab
Administered per the protocol
Other Names:
  • REGN4018
Drug: Sarilumab
Administered per the protocol
Other Names:
  • SAR153191
  • Kevzara®
  • REGN88

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
Time Frame: Up to 3 years
Up to 3 years
Complete Response (CR) rate by RECIST 1.1
Time Frame: Up to 3 years
Up to 3 years
Disease Control Rate (DCR) by RECIST 1.1
Time Frame: Up to 3 years
Up to 3 years
Duration Of Response (DOR) by RECIST 1.1
Time Frame: Up to 3 years
Up to 3 years
Progression-Free Survival (PFS) by RECIST 1.1
Time Frame: Up to 3 years
Up to 3 years
Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame: Up to 3 years
Up to 3 years
TEAEs by Lee criteria
Time Frame: Up to 3 years
Up to 3 years
Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria
Time Frame: Up to 3 years
Up to 3 years
Concentration of ubamatamab in serum
Time Frame: Up to 3 years
Up to 3 years
Concentration of fianlimab in serum
Time Frame: Up to 3 years
Up to 3 years
Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab
Time Frame: Up to 3 years
Up to 3 years
Magnitude of ADA to ubamatamab
Time Frame: Up to 3 years
Up to 3 years
Occurrence of ADA to fianlimab
Time Frame: Up to 3 years
Up to 3 years
Magnitude of ADA to fianlimab
Time Frame: Up to 3 years
Up to 3 years
Occurrence of ADA to cemiplimab
Time Frame: Up to 3 years
Up to 3 years
Magnitude of ADA to cemiplimab
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R4018-ONC-2445
  • 2024-517806-27-00 (Registry Identifier: EUCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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