Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
2 other identifiers
interventional
220
5 countries
52
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started May 2025
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
May 20, 2026
May 1, 2026
3.4 years
January 16, 2025
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Up to 3 years
Secondary Outcomes (16)
Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
Up to 3 years
Complete Response (CR) rate by RECIST 1.1
Up to 3 years
Disease Control Rate (DCR) by RECIST 1.1
Up to 3 years
Duration Of Response (DOR) by RECIST 1.1
Up to 3 years
Progression-Free Survival (PFS) by RECIST 1.1
Up to 3 years
- +11 more secondary outcomes
Study Arms (5)
Arm A1
EXPERIMENTALArm A2
EXPERIMENTALArm B
EXPERIMENTALArm C
EXPERIMENTALArm D
EXPERIMENTALInterventions
Administered per the protocol
Eligibility Criteria
You may qualify if:
- 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)
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function, as described in the protocol
- Platinum-Resistant Ovarian Cancer, as described in the protocol
You may not qualify if:
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
- Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
- Another malignancy that is progressing or requires active treatment, as described in the protocol
- Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
- Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
- Moderate to large or ascites, as described in the protocol
- Bowel obstruction within last 3 months or current need for parenteral nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
UC San Diego Health
La Jolla, California, 92037, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Advent Health Cancer Institute
Orlando, Florida, 32804, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606, United States
University of Chicago
Chicago, Illinois, 60637, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute, St. Matthews Clinic
Louisville, Kentucky, 40207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
The Ohio State University Comprehensive Cancer Center
Hilliard, Ohio, 43026, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
University of Pittsburgh Medical Center, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital of Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, 57105, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Research Institute - McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval
Québec, G1J 0J9, Canada
National Cancer Center
Gyeonggi-do, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, Seoul, 21565, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center, Univ. of Ulsan
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Gangnam Severance Hospital
Seoul, 135-720, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
Changhua Christian Hospital
Changhua, Changhua City, 500, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
National Taiwan University Hospital
Taipei, 106, Taiwan
Taipei Veterans General Hospital
Taipei, 11211, Taiwan
Tri-Service General Hospital
Taipei, 114202, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, 116, Taiwan
Medicalpark Seyhan Hospital
Seyhan, Adana, 01140, Turkey (Türkiye)
Hacettepe University
Altındağ, Ankara, 06240, Turkey (Türkiye)
Medipol University Hospital
Istanbul, Bagcilar, 34284, Turkey (Türkiye)
Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)
Baskent University
Adana, 01123, Turkey (Türkiye)
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
Ankara, 06100, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 0906520, Turkey (Türkiye)
Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa
Istanbul, 34450, Turkey (Türkiye)
Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)
Izmir, 35575, Turkey (Türkiye)
Sakarya University - Education and Research Hospital
Sakarya, 54290, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2025
First Posted
January 22, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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
- 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
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.