Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
a study on Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedstudy ends around
Description
Summary
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants 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, REGN10597 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
Official Title
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Keywords
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum Resistance, Ovarian Neoplasms, Fallopian Tube Neoplasms, Bevacizumab, cemiplimab, 1-dodecylpyridoxal, liposomal doxorubicin, sarilumab, Ubamatamab, Fianlimab, PLD, REGN10597
Eligibility
You can join if…
Open to females ages 18 years and up
- 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 CAN'T join 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
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Locations
- UC San Diego Health
accepting new patients
La Jolla California 92037 United States - Cedars Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Regeneron Pharmaceuticals
- ID
- NCT06787612
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 297 study participants
- Last Updated
Please contact me about this study
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Thank you!
The study team should get back to you in a few business days.