RecruitingPhase 2NCT06787612

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

Sponsor

Regeneron Pharmaceuticals

Enrollment

220 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ubamatamab in combination with other treatments for women with a type of ovarian cancer that has stopped responding to platinum-based chemotherapy (called platinum-resistant ovarian cancer). The goal is to find effective new options when standard treatments are no longer working. **You may be eligible if...** - You have been diagnosed with advanced serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - Your cancer has grown or spread despite platinum-based chemotherapy (platinum-resistant) - You have at least one measurable tumor on a scan - You are reasonably fit with good daily functioning (ECOG 0-1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You had major surgery or a serious injury within 4 weeks before starting treatment - You have had a severe allergic reaction to antibody-based treatments or doxorubicin - You have another active cancer that needs treatment - You have untreated cancer in the brain or spinal cord - You have HIV, active hepatitis B or C, or a significant immune deficiency - Your cancer type is clear cell, mucinous, or carcinosarcoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUbamatamab

Administered per the protocol

DRUGBevacizumab

Administered per the protocol

DRUGCemiplimab

Administered per the protocol

DRUGFianlimab

Administered per the protocol

DRUGPLD

Administered per the protocol

DRUGSarilumab

Administered per the protocol

Locations(50)

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

Advent Health Cancer Institute

Orlando, 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

West Penn Hospital of Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Research Institute - McGill University Health Centre

Montreal, Quebec, Canada

Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval

Québec, Canada

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)

Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)

Izmir, Turkey (Türkiye)

Sakarya University - Education and Research Hospital

Sakarya, Turkey (Türkiye)

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