> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/investigation-of-ubamatamab-combination-therapy-in-adult-571a016d-ba62-43ca-b0b5-d60047ff3fb0 > Record changed: 2026-10-13 # Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer NCT06787612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Participants 297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Start date 2025-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) Number of sites 55 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Short title** Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Dates **Completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **First posted** 2025-01-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Registry last updated** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Start date** 2025-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Size and sites **Participants** 297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Planned participants** 297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Number of sites** 55 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Identifiers **Registry ID** NCT06787612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **ClinicalTrials.gov ID** NCT06787612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Outcomes ### Primary outcomes 1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment Timeframe: Up to 3 years ### Secondary outcomes 1. Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria Timeframe: Up to 3 years 2. Complete Response (CR) rate by RECIST 1.1 Timeframe: Up to 3 years 3. Disease Control Rate (DCR) by RECIST 1.1 Timeframe: Up to 3 years 4. Duration of Response (DOR) by RECIST 1.1 Timeframe: Up to 3 years 5. Progression-Free Survival (PFS) by RECIST 1.1 Timeframe: Up to 3 years 6. Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria Timeframe: Up to 3 years 7. Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Timeframe: Up to 3 years 8. TEAEs by Lee criteria Timeframe: Up to 3 years 9. Concentration of ubamatamab in serum Timeframe: Up to 3 years 10. Concentration of fianlimab in serum Timeframe: Up to 3 years 11. Concentration of REGN10597 in serum Timeframe: Up to 3 years 12. Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab Timeframe: Up to 3 years 13. Magnitude of ADA to ubamatamab Timeframe: Up to 3 years 14. Occurrence of ADA to fianlimab Timeframe: Up to 3 years 15. Magnitude of ADA to fianlimab Timeframe: Up to 3 years 16. Occurrence of ADA to cemiplimab Timeframe: Up to 3 years 17. Magnitude of ADA to cemiplimab Timeframe: Up to 3 years 18. Occurrence of ADA to REGN10597 Timeframe: Up to 3 years 19. Magnitude of ADA to REGN10597 Timeframe: Up to 3 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Sites - The University of Alabama at BirminghamBirmingham, United StatesRecruiting - UC San Diego HealthLa Jolla, United StatesRecruiting - Cedars Sinai Medical CenterLos Angeles, United StatesRecruiting - Mayo Clinic JacksonvilleJacksonville, United StatesRecruiting - University of Miami Sylvester Comprehensive Cancer CenterMiami, United StatesRecruiting - Advent Health Cancer InstituteOrlando, United StatesRecruiting - Tampa General Hospital Cancer InstituteTampa, United StatesRecruiting - University of ChicagoChicago, United StatesRecruiting - The University of Kansas Cancer CenterWestwood, United StatesRecruiting - Norton Cancer Institute, St. Matthews ClinicLouisville, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - The Ohio State University Comprehensive Cancer CenterHilliard, United StatesRecruiting - Providence Cancer InstitutePortland, United StatesRecruiting - University of Pittsburgh Medical Center, Magee-Womens HospitalPittsburgh, United StatesRecruiting - West Penn Hospital of Allegheny Health NetworkPittsburgh, United StatesRecruiting - Avera Cancer Institute Sioux FallsSioux Falls, United StatesRecruiting - UT Southwestern Medical CenterDallas, United StatesRecruiting - Swedish Cancer InstituteSeattle, United StatesRecruiting - University of WisconsinMadison, United StatesRecruiting - Medical College of WisconsinMilwaukee, United StatesRecruiting - CancerCare ManitobaWinnipeg, CanadaRecruiting - Princess Margaret Cancer CentreToronto, CanadaRecruiting - Centre de Santé et de Services Sociaux de la Montérégie-CentreGreenfield Park, CanadaRecruiting - Jewish General HospitalMontreal, CanadaRecruiting And 30 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## References ### Other registry identifiers - 2024-517806-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06787612) ## Related records ### Drugs (5) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Cemiplimab](https://trialight.com/data/asset/cemiplimab-1c235a93-9b2c-4db0-9980-a78a93354b46.md) - [Fianlimab](https://trialight.com/data/asset/fianlimab-90c791f8-25bd-4882-8311-8dd34d92ebc7.md) - [Sarilumab](https://trialight.com/data/asset/sarilumab-3c9e967c-0b03-4fb4-9d41-9c1c309270be.md) - [Ubamatamab](https://trialight.com/data/asset/ubamatamab-8b11cb87-3e84-42e6-9739-f86e1ad58449.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (5) - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) Primary condition - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Primary peritoneal carcinoma](https://trialight.com/data/condition/primary-peritoneal-carcinoma-9bb0e4b4-cb5a-5d56-8331-331c250af14d.md) ### Targets (4) - [IL6R](https://trialight.com/data/target/il6r-c7147d9a-d486-5e5b-9263-4bf4c1ee3a1a.md) - [LAG3](https://trialight.com/data/target/lag3-9427165f-23d0-56e2-8aec-0a1f9a15edc3.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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