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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, 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

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
University of Miami Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Tampa General Hospital Cancer Institute
RECRUITING
Tampa
Kansas
The University of Kansas Cancer Center
RECRUITING
Westwood
Kentucky
Norton Cancer Institute, St. Matthews Clinic
RECRUITING
Louisville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Ohio
The Ohio State University Comprehensive Cancer Center
RECRUITING
Hilliard
South Dakota
Avera Cancer Institute Sioux Falls
RECRUITING
Sioux Falls
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
Republic of Korea
Keimyung University Dongsan Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Gyeonggi-do
Gachon University Gil Medical Center
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center, Univ. of Ulsan
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Chi Mei Medical Center
RECRUITING
Tainan
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Turkey
Baskent University
RECRUITING
Adana
Hacettepe University
RECRUITING
Altındağ
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
RECRUITING
Ankara
Sakarya University - Education and Research Hospital
RECRUITING
Sakarya
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2028-12-07
Participants
Target number of participants: 220
Treatments
Experimental: Arm A1
Randomization as described in the protocol
Experimental: Arm A2
Randomization as described in the protocol
Experimental: Arm B
Randomization as described in the protocol
Experimental: Arm C
Randomization as described in the protocol
Experimental: Arm D
Randomization as described in the protocol
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov