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

RecruitingPhase 2

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Regeneron Pharmaceuticals · Participants: 297 · Started: May 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06787612

Locations in the U.S.

AlabamaThe University of Alabama at Birmingham, Birmingham
CaliforniaUC San Diego Health, La Jolla
Cedars Sinai Medical Center, Los Angeles
FloridaMayo Clinic Jacksonville, Jacksonville
University of Miami Sylvester Comprehensive Cancer Center, Miami
Advent Health Cancer Institute, Orlando
Tampa General Hospital Cancer Institute, Tampa
IllinoisUniversity of Chicago, Chicago
KansasThe University of Kansas Cancer Center, Westwood
KentuckyNorton Cancer Institute, St. Matthews Clinic, Louisville
MassachusettsMassachusetts General Hospital, Boston
MichiganKarmanos Cancer Institute, Detroit
OhioThe Ohio State University Comprehensive Cancer Center, Hilliard
OregonProvidence Cancer Institute, Portland
PennsylvaniaUniversity of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh
West Penn Hospital of Allegheny Health Network, Pittsburgh
South DakotaAvera Cancer Institute Sioux Falls, Sioux Falls
TexasUT Southwestern Medical Center, Dallas
WashingtonSwedish Cancer Institute, Seattle
WisconsinUniversity of Wisconsin, Madison
Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.