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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment297 people
  • Recruiting US sites21
  • SponsorRegeneron Pharmaceuticals
  • RegistryNCT06787612

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer: a one-minute explainerNCT067876121 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexFemale
  • Healthy volunteersNo

You may be able to join if

  • Key Inclusion Criteria:
  • 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
  • Key Exclusion Criteria:
  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ubamatamab. A bispecific, human monoclonal antibody with potential antineoplastic activity. REGN4018 contains two antigen-recognition sites: one for human CD3, a T-cell surface antigen that is part of the T-cell receptor complex, and one for human mucin 16 (MUC16, cancer antigen 125; CA125; FLJ14303), a member of the mucin family of glycoproteins that is overexpressed by several epithelial cancers, including ovarian cancer. Upon administration, ubamatamab binds to both T cells and MUC16-expressing tumor cells, which cross-links the T cells to the tumor cells, and may result in a potent cytotoxic T-lymphocyte (CTL) response against the MUC16-expressing tumor cells. NCI Drug Dictionary

Treatments listed in the registry

  • Ubamatamab (Drug): Administered per the protocol
  • Bevacizumab (Drug): Administered per the protocol
  • Cemiplimab (Drug): Administered per the protocol
  • Fianlimab (Drug): Administered per the protocol
  • PLD (Drug): Administered per the protocol
  • Sarilumab (Drug): Administered per the protocol
  • REGN10597 (Drug): Administered per the protocol

The study

Treatment groups

Randomized · Parallel · masking: None

Arm A1 (Experimental)

Arm A2 (Experimental)

Arm B (Experimental)

Arm C (Experimental)

Arm D (Experimental)

Arms E1/E2 (Experimental)

Goals

What the study measures

Main goals

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment (Up to 3 years)

Other goals

  • Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
  • Complete Response (CR) rate by RECIST 1.1
  • Disease Control Rate (DCR) by RECIST 1.1
  • Duration of Response (DOR) by RECIST 1.1
  • Progression-Free Survival (PFS) by RECIST 1.1
  • Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria
  • Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • TEAEs by Lee criteria
  • Concentration of ubamatamab in serum
  • Concentration of fianlimab in serum
  • Concentration of REGN10597 in serum
  • Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab
  • Magnitude of ADA to ubamatamab
  • Occurrence of ADA to fianlimab
  • Magnitude of ADA to fianlimab
  • Occurrence of ADA to cemiplimab
  • Magnitude of ADA to cemiplimab
  • Occurrence of ADA to REGN10597
  • Magnitude of ADA to REGN10597

Planned enrollment: 297 (estimated).

Where

Recruiting US sites

  • The University of Alabama at Birmingham, Birmingham, Alabama
  • UC San Diego Health, La Jolla, California
  • Cedars Sinai Medical Center, Los Angeles, California
  • Mayo Clinic Jacksonville, Jacksonville, Florida
  • University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida
  • Advent Health Cancer Institute, Orlando, Florida
  • Tampa General Hospital Cancer Institute, Tampa, Florida
  • University of Chicago, Chicago, Illinois
  • The University of Kansas Cancer Center, Westwood, Kansas
  • Norton Cancer Institute, St. Matthews Clinic, Louisville, Kentucky
  • Massachusetts General Hospital, Boston, Massachusetts
  • Karmanos Cancer Institute, Detroit, Michigan
  • The Ohio State University Comprehensive Cancer Center, Hilliard, Ohio
  • Providence Cancer Institute, Portland, Oregon
  • University of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh, Pennsylvania
  • West Penn Hospital of Allegheny Health Network, Pittsburgh, Pennsylvania
  • Avera Cancer Institute Sioux Falls, Sioux Falls, South Dakota
  • UT Southwestern Medical Center, Dallas, Texas
  • Swedish Cancer Institute, Seattle, Washington
  • University of Wisconsin, Madison, Wisconsin
  • Medical College of Wisconsin, Milwaukee, Wisconsin

35 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 13, 2026. Public record; not medical advice.

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