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Recruiting

NCT Number: NCT06787612

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

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

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ubamatamab

Drug

Administered per the protocol

Other names: REGN4018

Bevacizumab

Drug

Administered per the protocol

Other names: Avastin®

cemiplimab

Drug

Administered per the protocol

Other names: Libtayo®, REGN2810

Fianlimab

Drug

Administered per the protocol

Other names: REGN3767

PLD

Drug

Administered per the protocol

Other names: Doxil®, Pegylated liposomal doxorubicin

Sarilumab

Drug

Administered per the protocol

Other names: Kevzara®, REGN88, SAR153191

Primary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment

    Time frame: Up to 3 years

Secondary outcomes

  1. Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria

    Time frame: Up to 3 years

  2. Complete Response (CR) rate by RECIST 1.1

    Time frame: Up to 3 years

  3. Disease Control Rate (DCR) by RECIST 1.1

    Time frame: Up to 3 years

  4. Duration Of Response (DOR) by RECIST 1.1

    Time frame: Up to 3 years

  5. Progression-Free Survival (PFS) by RECIST 1.1

    Time frame: Up to 3 years

  6. Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria

    Time frame: Up to 3 years

  7. Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Time frame: Up to 3 years

  8. TEAEs by Lee criteria

    Time frame: Up to 3 years

  9. Concentration of ubamatamab in serum

    Time frame: Up to 3 years

  10. Concentration of fianlimab in serum

    Time frame: Up to 3 years

  11. Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab

    Time frame: Up to 3 years

  12. Magnitude of ADA to ubamatamab

    Time frame: Up to 3 years

  13. Occurrence of ADA to fianlimab

    Time frame: Up to 3 years

  14. Magnitude of ADA to fianlimab

    Time frame: Up to 3 years

  15. Occurrence of ADA to cemiplimab

    Time frame: Up to 3 years

  16. Magnitude of ADA to cemiplimab

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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