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Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Trial Status: active
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
Inclusion Criteria
Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, 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 Key
Exclusion Criteria
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s)
Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
Another malignancy that is progressing or requires active treatment, as described in the protocol
Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, 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 NOTE: Other protocol-defined inclusion/exclusion criteria apply
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06787612.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University Hospital