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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (NCT06787612) is a Phase 2 interventional studying Ovarian Cancer and Fallopian Tube Cancer, sponsored by Regeneron Pharmaceuticals. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 220 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Participants with diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: 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 weakened immune system virus, hepatitis B or hepatitis C infection, or diagnosis of weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Ubamatamab

Administered per the protocol

DRUG

Bevacizumab

Administered per the protocol

DRUG

Cemiplimab

Administered per the protocol

DRUG

Fianlimab

Administered per the protocol

DRUG

PLD

Administered per the protocol

DRUG

Sarilumab

Administered per the protocol

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
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
Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, 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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06787612), the sponsor (Regeneron Pharmaceuticals), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06787612 clinical trial studying?

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 expe… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06787612?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06787612?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06787612. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06787612. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.