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NCT06787612PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

5/28/2025

Completion Date

10/30/2028

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Ubamatamab

DRUG

Bevacizumab

DRUG

Cemiplimab

DRUG

Fianlimab

DRUG

PLD

DRUG

Sarilumab

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Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Locations

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

CancerCare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Centre de Santé et de Services Sociaux de la Montérégie-Centre

Greenfield Park, Quebec J4V 2H1

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)