Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
NCT ID: NCT06787612
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2025-05-28
2028-12-07
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A1
Randomization as described in the protocol
Ubamatamab
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Arm A2
Randomization as described in the protocol
Ubamatamab
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Arm B
Randomization as described in the protocol
Ubamatamab
Administered per the protocol
Bevacizumab
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Arm C
Randomization as described in the protocol
Ubamatamab
Administered per the protocol
Cemiplimab
Administered per the protocol
Fianlimab
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Arm D
Randomization as described in the protocol
Ubamatamab
Administered per the protocol
PLD
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Interventions
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Ubamatamab
Administered per the protocol
Bevacizumab
Administered per the protocol
Cemiplimab
Administered per the protocol
Fianlimab
Administered per the protocol
PLD
Administered per the protocol
Sarilumab
Prophylaxis administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, 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
18 Years
FEMALE
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Health
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews Clinic
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
The Ohio State University Comprehensive Cancer Center
Hilliard, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
National Cancer Center
Gyeonggi-do, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, Seoul, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center, Univ. of Ulsan
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Changhua Christian Hospital
Changhua, Changhua City, Taiwan
Chi Mei Medical Center
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Medicalpark Seyhan Hospital
Seyhan, Adana, Turkey (Türkiye)
Hacettepe University
Altındağ, Ankara, Turkey (Türkiye)
Medipol University Hospital
Istanbul, Bagcilar, Turkey (Türkiye)
Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil, Turkey (Türkiye)
Baskent University
Adana, , Turkey (Türkiye)
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa
Istanbul, , Turkey (Türkiye)
Sakarya University - Education and Research Hospital
Sakarya, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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R4018-ONC-2445
Identifier Type: -
Identifier Source: org_study_id
2024-517806-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
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