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A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804 · Eli Lilly and Company
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Official title
FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
About this study
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Eligibility criteria
Inclusion Criteria: Part A and B: * Have histologically confirmed high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer. * Have confirmed availability of tumor tissue block or slides * Have radiographic progression on or after most recent line of systemic anticancer therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Have measurable disease per RECIST v1.1 Part A: * Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy. * Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine. * Have received prior bevacizumab treatment, unless documented contraindication or intolerance. * Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance. Part B: * Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy * Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy * Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment. Exclusion Criteria: Part A and B: \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: \- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy. Part B: \- Have clinically significant proteinuria
Study design
Enrollment target: 1080 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-22
Estimated completion: 2031-08
Last updated: 2026-04-17
Interventions
Drug: Sofetabart MipitecanDrug: PaclitaxelDrug: TopotecanDrug: GemcitabineDrug: Pegylated liposomal doxorubicin (PLD)Drug: MIRVDrug: BevacizumabDrug: Carboplatin
Primary outcomes
  • Progression-free Survival (PFS) (Randomization to radiographic progression or death from any cause (up to 70 months))
Sponsor
Eli Lilly and Company · industry
With: GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Contacts & investigators
ContactTrial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (260)
University of Alabama at BirminghamNot Yet Recruiting
Birmingham, Alabama, United States
HonorHealthNot Yet Recruiting
Phoenix, Arizona, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterNot Yet Recruiting
Burbank, California, United States
City of Hope, DuarteNot Yet Recruiting
Duarte, California, United States
Moores Cancer CenterNot Yet Recruiting
La Jolla, California, United States
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Los Angeles, California, United States
Stanford Women's Cancer CenterNot Yet Recruiting
Palo Alto, California, United States
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San Diego, California, United States
Sansum ClinicRecruiting
Santa Barbara, California, United States
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Vallejo, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Florida Cancer Specialist- SouthNot Yet Recruiting
Fort Myers, Florida, United States
Baptist MD Anderson Cancer CenterNot Yet Recruiting
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer CenterNot Yet Recruiting
Miami, Florida, United States
Mount Sinai Comprehensive Cancer CenterNot Yet Recruiting
Miami Beach, Florida, United States
AdventHealth OrlandoNot Yet Recruiting
Orlando, Florida, United States
Moffitt Cancer CenterNot Yet Recruiting
Tampa, Florida, United States
Florida Cancer Specialist- EastNot Yet Recruiting
West Palm Beach, Florida, United States
Winship Cancer Institute, Emory UniversityNot Yet Recruiting
Atlanta, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research PavillionNot Yet Recruiting
Savannah, Georgia, United States
Kapiolani Medical Center for Women and ChildrenNot Yet Recruiting
Honolulu, Hawaii, United States
Illinois Cancer SpecialistsRecruiting
Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
OSF Saint Fracis Medical CenterNot Yet Recruiting
Peoria, Illinois, United States
Franciscan HealthNot Yet Recruiting
Indianapolis, Indiana, United States
Baptist Health LexingtonNot Yet Recruiting
Lexington, Kentucky, United States
Norton Women's and Children's HospitalNot Yet Recruiting
Louisville, Kentucky, United States
Ochsner Clinic FoundationNot Yet Recruiting
New Orleans, Louisiana, United States
Trials 365Recruiting
Shreveport, Louisiana, United States
Maine Medical Center - Scarborough CampusNot Yet Recruiting
Scarborough, Maine, United States
Greater Baltimore Medical CenterNot Yet Recruiting
Baltimore, Maryland, United States
Sinai Hospital Of BaltimoreNot Yet Recruiting
Baltimore, Maryland, United States
University of Massachusetts Chan Medical SchoolNot Yet Recruiting
Worcester, Massachusetts, United States
Karmanos Cancer InstituteNot Yet Recruiting
Detroit, Michigan, United States
West Michigan Cancer CenterNot Yet Recruiting
Kalamazoo, Michigan, United States
Mayo Clinic in Rochester, MinnesotaNot Yet Recruiting
Rochester, Minnesota, United States
University of Missouri HospitalNot Yet Recruiting
Columbia, Missouri, United States
HCA Midwest Kansas City, MidAmerica Division, Inc.Not Yet Recruiting
Kansas City, Missouri, United States
Cox Medical Center NorthNot Yet Recruiting
Springfield, Missouri, United States
The Center of HopeNot Yet Recruiting
Reno, Nevada, United States
Dartmouth-Hitchcock Medical CenterNot Yet Recruiting
Lebanon, New Hampshire, United States
Holy Name Medical CenterNot Yet Recruiting
Teaneck, New Jersey, United States
Optimum Clinical Research GroupNot Yet Recruiting
Albuquerque, New Mexico, United States
Roswell Park Cancer InstituteNot Yet Recruiting
Buffalo, New York, United States
Northwell Health/ RJ Zuckerberg Cancer CenterNot Yet Recruiting
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandRecruiting
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer CenterRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiNot Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Levine Cancer InstituteNot Yet Recruiting
Charlotte, North Carolina, United States
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Durham, North Carolina, United States
Miami Valley Hospital SouthRecruiting
Centerville, Ohio, United States
University of Cincinnati Medical CenterNot Yet Recruiting
Cincinnati, Ohio, United States
Oncology Hematology Care IncRecruiting
Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Sylvania, Ohio, United States
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Eugene, Oregon, United States
Providence Portland Medical CenterNot Yet Recruiting
Portland, Oregon, United States
Kaiser Permanente Interstate Medical Office CentralRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityNot Yet Recruiting
Portland, Oregon, United States
University of Pennsylvania HospitalNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Asplundh Cancer PavilionNot Yet Recruiting
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Women & Infants HospitalNot Yet Recruiting
Providence, Rhode Island, United States
Medical University of South CarolinaNot Yet Recruiting
Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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The Woodlands, Texas, United States
US OncologyRecruiting
The Woodlands, Texas, United States
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Webster, Texas, United States
Huntsman Cancer InstituteNot Yet Recruiting
Salt Lake City, Utah, United States
Swedish Cancer Institute - EdmondsNot Yet Recruiting
Edmonds, Washington, United States
Swedish Medical CenterNot Yet Recruiting
Seattle, Washington, United States
Fred Hutchinson Cancer CenterNot Yet Recruiting
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - University HospitalNot Yet Recruiting
Madison, Wisconsin, United States
Ballarat Health ServicesNot Yet Recruiting
Ballarat Central, Australia
Chris O'Brien LifehouseNot Yet Recruiting
Camperdown, Australia
Launceston General HospitalNot Yet Recruiting
Launceston, Australia
Cabrini Hospital - MalvernNot Yet Recruiting
Malvern, Australia
Prince of Wales HospitalNot Yet Recruiting
Randwick, Australia
Goulburn Valley HealthNot Yet Recruiting
Shepparton, Australia
Gold Coast University HospitalNot Yet Recruiting
Southport, Australia
Royal North Shore HospitalNot Yet Recruiting
St Leonards, Australia
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Townsville, Australia
Latrobe Regional HealthNot Yet Recruiting
Traralgon, Australia
Medizinische Universität GrazNot Yet Recruiting
Graz, Austria
Medizinische Universitaet InnsbruckNot Yet Recruiting
Innsbruck, Austria
Universitaetsklinikum Allgemeines Krankenhaus WienNot Yet Recruiting
Vienna, Austria
Institut Jules BordetNot Yet Recruiting
Anderlecht, Belgium
AZ Sint-Jan Brugge-Oostende AVNot Yet Recruiting
Bruges, Belgium
Antwerp University HospitalNot Yet Recruiting
Edegem, Belgium
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Ghent, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
CPAM - Centro de Pesquisas da AmazôniaNot Yet Recruiting
Belém, Brazil
Oncocentro de Minas GeraisNot Yet Recruiting
Belo Horizonte, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa CatarinaNot Yet Recruiting
Florianópolis, Brazil
Hospital BrasiliaNot Yet Recruiting
Lago Sul, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SANot Yet Recruiting
Rio de Janeiro, Brazil
Instituto D'Or Pesquisa e EnsinoNot Yet Recruiting
Rio de Janeiro, Brazil
Clinica Amo - Rio VermelhoNot Yet Recruiting
Salvador, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do SulNot Yet Recruiting
São Caetano do Sul, Brazil
Arthur J.E. Child Comprehensive Cancer CentreNot Yet Recruiting
Calgary, Canada
Hamilton Health Sciences-Juravinski Cancer CentreNot Yet Recruiting
Hamilton, Canada
Jewish General HospitalNot Yet Recruiting
Montreal, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -TNot Yet Recruiting
Sherbrooke, Canada
BC Cancer SurreyNot Yet Recruiting
Surrey, Canada
Sunnybrook Research InstituteNot Yet Recruiting
Toronto, Canada
Princess Margaret Cancer CentreNot Yet Recruiting
Toronto, Canada
Peking University First HospitalNot Yet Recruiting
Beijing, China
Beijing Cancer hospitalNot Yet Recruiting
Beijing, China
The First Hospital of Jilin UniversityNot Yet Recruiting
Changchun, China
The First People's Hospital of Changde CityNot Yet Recruiting
Changde, China
Xiangya Hospital Central South UniversityNot Yet Recruiting
Changsha, China
West China Second University Hospital, Sichuan UniversityNot Yet Recruiting
Chengdu, China
Sichuan Provincial People's HospitalNot Yet Recruiting
Chengdu, China
Fujian Cancer HospitalNot Yet Recruiting
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityNot Yet Recruiting
Guangzhou, China
Zhujiang HospitalNot Yet Recruiting
Guangzhou, China
Sun Yat-Sen University Cancer CentreNot Yet Recruiting
Guangzhou, China
Zhejiang Cancer HospitalNot Yet Recruiting
Hangzhou, China
Shandong Cancer HospitalNot Yet Recruiting
Jinan, China
Gansu Provincial Maternity and Child Care HospitalNot Yet Recruiting
Lanzhou, China
The First Affiliated Hospital of Henan University of Science &TechnologyNot Yet Recruiting
Luoyang, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNot Yet Recruiting
Nanjing, China
Jiangsu Province HospitalNot Yet Recruiting
Nanjing, China
Guangxi Medical University Affiliated Tumor HospitalNot Yet Recruiting
Nanning, China
Obstetrics & Gynecology Hospital of Fudan UniversityNot Yet Recruiting
Shanghai, China
Fudan University Shanghai Cancer CenterNot Yet Recruiting
Shanghai, China
Cancer Hospital of Shantou University Medical CollegeNot Yet Recruiting
Shantou, China
Peking University Shenzhen HospitalNot Yet Recruiting
Shenzhen, China
Tianjin Medical University Cancer Institute & HospitalNot Yet Recruiting
Tianjin, China
Wuhan Union HospitalNot Yet Recruiting
Wuhan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyNot Yet Recruiting
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong UniversityNot Yet Recruiting
Xi'an, China
Fakultní Nemocnice BrnoNot Yet Recruiting
Brno, Czechia
Nemocnice AGEL Novy Jicin a.s.Not Yet Recruiting
Nový Jiín, Czechia
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Olomouc, Czechia
Vseobecna fakultni nemocnice v PrazeNot Yet Recruiting
Prague, Czechia
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RigshospitaletNot Yet Recruiting
Copenhagen, Denmark
Vejle SygehusNot Yet Recruiting
Vejle, Denmark
Institut de Cancérologie de l'OuestNot Yet Recruiting
Angers, France
Centre Hospitalier de la Côte BasqueNot Yet Recruiting
Bayonne, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestNot Yet Recruiting
Bordeaux, France
CHRU de BrestNot Yet Recruiting
Brest, France
Centre Oscar LambretNot Yet Recruiting
Lille, France
Centre Hospitalier Universitaire de Limoges - Hôpital DupuytrenNot Yet Recruiting
Limoges, France
Centre Leon BerardNot Yet Recruiting
Lyon Cedex08, France
Institut Régional du Cancer MontpellierNot Yet Recruiting
Montpellier, France
Hopitaux Universitaires Paris Centre-Hopital CochinNot Yet Recruiting
Paris, France
Groupe Hospitalier Diaconesses Croix Saint SimonNot Yet Recruiting
Paris, France
CHU Strasbourg-HautepierreNot Yet Recruiting
Strasbourg, France
Universitätsklinikum AachenNot Yet Recruiting
Aachen, Germany
Charité Campus Virchow-KlinikumNot Yet Recruiting
Berlin, Germany
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Cologne, Germany
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Universitaetsklinikum DuesseldorfNot Yet Recruiting
Düsseldorf, Germany
Universitaetsklinikum ErlangenNot Yet Recruiting
Erlangen, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-StiftungNot Yet Recruiting
Essen, Germany
Universitaetsklinikum Schleswig-Holstein Campus KielNot Yet Recruiting
Kiel, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Germany
Alexandra HospitalNot Yet Recruiting
Athens, Greece
Aretaieio HospitalNot Yet Recruiting
Athens, Greece
General Hospital of KalamataNot Yet Recruiting
Kalamata, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"Not Yet Recruiting
Nea Kifissia, Greece
Országos Onkológiai IntézetNot Yet Recruiting
Budapest, Hungary
Debreceni Egyetem Klinikai KozpontNot Yet Recruiting
Debrecen, Hungary
Petz Aladar Egyetemi Oktato KorhazNot Yet Recruiting
Győr, Hungary
Cork University HospitalNot Yet Recruiting
Cork, Ireland
St. Vincent's University HospitalNot Yet Recruiting
Dublin, Ireland
St. James's HospitalNot Yet Recruiting
Dublin, Ireland
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaNot Yet Recruiting
Bologna, Italy
Ospedale CannizzaroNot Yet Recruiting
Catania, Italy
Ospedale Vito FazziNot Yet Recruiting
Lecce, Italy
Azienda USL 2 LuccaNot Yet Recruiting
Lucca, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriNot Yet Recruiting
Milan, Italy
Istituto Europeo di Oncologia IRCCSNot Yet Recruiting
Milan, Italy
Ospedale Humanitas San Pio XNot Yet Recruiting
Milan, Italy
Azienda Ospedaliero UniversitariaNot Yet Recruiting
Modena, Italy
Istituto Nazionale Tumori IRCCS Fondazione PascaleNot Yet Recruiting
Naples, Italy
Nuovo Ospedale di Prato-S.StefanoNot Yet Recruiting
Prato, Italy
Ospedale Santa Maria delle CrociNot Yet Recruiting
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreNot Yet Recruiting
Roma, Italy
Hyogo Cancer CenterNot Yet Recruiting
Akashi, Japan
National Cancer Center HospitalNot Yet Recruiting
Chūōku, Japan
National Hospital Organization Kyushu Cancer CenterNot Yet Recruiting
Fukuoka, Japan
Saitama Medical University International Medical CenterNot Yet Recruiting
Hidaka, Japan
Kagoshima University HospitalNot Yet Recruiting
Kagoshima, Japan
National Cancer Center Hospital EastNot Yet Recruiting
Kashiwa, Japan
The Cancer Institute Hospital of JFCRNot Yet Recruiting
Kōtoku, Japan
Nagoya University HospitalNot Yet Recruiting
Nagoya, Japan
Niigata Cancer Center HospitalNot Yet Recruiting
Niigata, Japan
Okayama University HospitalNot Yet Recruiting
Okayama, Japan
Gunma Prefectural Cancer CenterNot Yet Recruiting
Otashi, Japan
Hokkaido University HospitalNot Yet Recruiting
Sapporo, Japan
Tohoku University HospitalNot Yet Recruiting
Sendai, Japan
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Shiwa-gun Yahaba-cho, Japan
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Ehime University HospitalNot Yet Recruiting
Tōon, Japan
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Tsu, Japan
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Higiea OncologiaNot Yet Recruiting
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Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-CurieNot Yet Recruiting
Poznan, Poland
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Institutul Regional de OncologieNot Yet Recruiting
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Timișoara, Romania
Keimyung University Dongsan HospitalNot Yet Recruiting
Daegu, South Korea
National Cancer CenterNot Yet Recruiting
Goyang-si, South Korea
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Asan Medical CenterNot Yet Recruiting
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Barcelona, Spain
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Chur, Switzerland
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Chang Gung Memorial Hospital at KaohsiungNot Yet Recruiting
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Taichung Veterans General HospitalNot Yet Recruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
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Mackay Memorial HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
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Bath, United Kingdom
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Leeds, United Kingdom
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The Christie NHS Foundation TrustNot Yet Recruiting
Manchester, United Kingdom
Torbay HospitalNot Yet Recruiting
Torquay, United Kingdom
A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer · TrialPath