TrialPath
Recruiting

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

NCT06787612 · Regeneron Pharmaceuticals
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
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
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
Study design
Enrollment target: 220 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-28
Estimated completion: 2028-10-30
Last updated: 2026-05-20
Interventions
Drug: UbamatamabDrug: BevacizumabDrug: CemiplimabDrug: FianlimabDrug: PLDDrug: Sarilumab
Primary outcomes
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment (Up to 3 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (52)
The University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
UC San Diego HealthRecruiting
La Jolla, California, United States
Cedars Sinai Medical CenterRecruiting
Los Angeles, California, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
Advent Health Cancer InstituteRecruiting
Orlando, Florida, United States
Tampa General Hospital Cancer InstituteRecruiting
Tampa, Florida, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
The University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews ClinicRecruiting
Louisville, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Hilliard, Ohio, United States
Providence Cancer InstituteRecruiting
Portland, Oregon, United States
University of Pittsburgh Medical Center, Magee-Womens HospitalRecruiting
Pittsburgh, Pennsylvania, United States
West Penn Hospital of Allegheny Health NetworkRecruiting
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute Sioux FallsRecruiting
Sioux Falls, South Dakota, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Research Institute - McGill University Health CentreRecruiting
Montreal, Quebec, Canada
Centre Hospitalier Universitaire (CHU) de Quebec - Universite LavalRecruiting
Québec, Canada
National Cancer CenterRecruiting
Gyeonggi-do, Gyeonggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, Seoul, South Korea
Keimyung University Dongsan HospitalRecruiting
Daegu, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center, Univ. of UlsanRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Gangnam Severance HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Changhua Christian HospitalRecruiting
Changhua, Changhua City, Taiwan
Chi Mei Medical CenterRecruiting
Tainan, Taiwan
Mackay Memorial HospitalRecruiting
Taipei, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Taipei Municipal Wan Fang HospitalRecruiting
Taipei, Taiwan
Medicalpark Seyhan HospitalRecruiting
Seyhan, Adana, Turkey (Türkiye)
Hacettepe UniversityRecruiting
Altındağ, Ankara, Turkey (Türkiye)
Medipol University HospitalRecruiting
Istanbul, Bagcilar, Turkey (Türkiye)
Gaziantep Medicalpoint HospitalRecruiting
Gaziantep, Sehitkamil, Turkey (Türkiye)
Baskent UniversityRecruiting
Adana, Turkey (Türkiye)
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji SuamRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent City HospitalRecruiting
Ankara, Turkey (Türkiye)
Memorial Ankara HospitalRecruiting
Ankara, Turkey (Türkiye)
Cerrahpasa Medical Faculty At Istanbul University CerrahpasaRecruiting
Istanbul, Turkey (Türkiye)
Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)Recruiting
Izmir, Turkey (Türkiye)
Sakarya University - Education and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer · TrialPath