A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Start Date
10/22/2025
Completion Date
8/1/2031
Summary
This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard 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
Age Range: 18 years to No maximum
Interventions
Sofetabart Mipitecan
Paclitaxel
Topotecan
Gemcitabine
Pegylated liposomal doxorubicin (PLD)
MIRV
Bevacizumab
Carboplatin
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
HonorHealth
Phoenix, Arizona 85016
United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California 91505
United States
City of Hope, Duarte
Duarte, California 91010
United States
City of Hope Lennar
Irvine, California 92618
United States
Kaiser Permanente Zion Medical Center
Irvine, California 92618
United States
Moores Cancer Center
La Jolla, California 92093
United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California 90095
United States
Stanford Women's Cancer Center
Palo Alto, California 94305
United States
Sansum Clinic
Santa Barbara, California 93105
United States
Kaiser Permanente
Vallejo, California 94589
United States
Anschutz Cancer Pavilion
Aurora, Colorado 80045
United States
AdventHealth Medical Group - Porter
Denver, Colorado 80210
United States
UConn Health
Farmington, Connecticut 06030-8010
United States
Broward Health Medical Center
Fort Lauderdale, Florida 33316
United States
Florida Cancer Specialist- South
Fort Myers, Florida 33901
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
United States
Mount Sinai Braman Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Florida Cancer Specialist- East
West Palm Beach, Florida 33401
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia 31405
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
The University of Chicago Medicine
Chicago, Illinois 60637
United States
OSF Saint Fracis Medical Center
Peoria, Illinois 61637
United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Franciscan Health
Indianapolis, Indiana 46237
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536
United States
Norton Women's and Children's Hospital
Louisville, Kentucky 40207
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Trials 365
Shreveport, Louisiana 71103
United States
Maine Medical Center - Scarborough Campus
Scarborough, Maine 04074
United States
Greater Baltimore Medical Center
Baltimore, Maryland 21204
United States
Sinai Hospital Of Baltimore
Baltimore, Maryland 21215
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01605
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
United States
University of Missouri Hospital
Columbia, Missouri 65212
United States
HCA Midwest Kansas City, MidAmerica Division, Inc.
Kansas City, Missouri 64132
United States
Cox Medical Center North
Springfield, Missouri 65802
United States
The Center of Hope
Reno, Nevada 89511
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Optimum Clinical Research Group
Albuquerque, New Mexico 87109
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York 11042
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Oncology Hematology Care Inc
Cincinnati, Ohio 45242
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Mark H Zangmeister Center
Columbus, Ohio 43219
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Hilliard, Ohio 43026
United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124
United States
ProMedica Flower Hospital
Sylvania, Ohio 43560
United States
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon 97401
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon 97227
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania 19107
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Women & Infants Hospital
Providence, Rhode Island 02905
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
USO-Texas Oncology-Central/South Texas
Austin, Texas 78731
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
US Oncology
The Woodlands, Texas 77380
United States
US Oncology
The Woodlands, Texas 77380
United States
USO - Texas Oncology Gulf Coast
Webster, Texas 77598-4420
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington 98026
United States
Swedish Medical Center
Seattle, Washington 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Ballarat Health Services
Ballarat Central, 3350
Australia
Chris O'Brien Lifehouse
Camperdown, 2050
Australia
Launceston General Hospital
Launceston, 7250
Australia
Cabrini Hospital - Malvern
Malvern, 3144
Australia
Prince of Wales Hospital
Randwick, 2031
Australia
Goulburn Valley Health
Shepparton, 3630
Australia
Gold Coast University Hospital
Southport, 4215
Australia
Royal North Shore Hospital
St Leonards, 2065
Australia
The Townsville Hospital
Townsville, 4814
Australia
Latrobe Regional Health
Traralgon, 3844
Australia
Medizinische Universität Graz
Graz, 8036
Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Austria
Institut Jules Bordet
Anderlecht, 1070
Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000
Belgium
Antwerp University Hospital
Edegem, 2650
Belgium
AZ Maria Middelares
Ghent, 9000
Belgium
UZ Leuven
Leuven, 3000
Belgium
CPAM - Centro de Pesquisas da Amazônia
Belém, 66063-495
Brazil
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060
Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, 88020-210
Brazil
Hospital Brasilia
Lago Sul, 71635580
Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22271-110
Brazil
Clinica Amo - Rio Vermelho
Salvador, 41950-640
Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, 09541-270
Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2
Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, L8V5C2
Canada
Jewish General Hospital
Montreal, H3T 1E2
Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke, J1H 5N4
Canada
BC Cancer Surrey
Surrey, V3V 1Z2
Canada
Sunnybrook Research Institute
Toronto, M4N 3M5
Canada
Princess Margaret Cancer Centre
Toronto, M5G 2M9
Canada
Peking University First Hospital
Beijing, 100032
China
Beijing Cancer hospital
Beijing, 100142
China
The First Hospital of Jilin University
Changchun, 130021
China
The First People's Hospital of Changde City
Changde, 415003
China
Xiangya Hospital Central South University
Changsha, 410008
China
Sichuan Provincial People's Hospital
Chengdu, 610072
China
Fujian Cancer Hospital
Fuzhou, 350014
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
China
Zhujiang Hospital
Guangzhou, 510280
China
Sun Yat-Sen University Cancer Centre
Guangzhou, 511400
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
Shandong Cancer Hospital
Jinan, 250117
China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, 730050
China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471023
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000
China
Jiangsu Province Hospital
Nanjing, 210029
China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021
China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200011; 200090
China
Fudan University Shanghai Cancer Center
Shanghai, 200032
China
Cancer Hospital of Shantou University Medical College
Shantou, 515031
China
Peking University Shenzhen Hospital
Shenzhen, 518036
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
China
Wuhan Union Hospital
Wuhan, 430022
China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
China
Fakultní Nemocnice Brno
Brno, 602 00
Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jiín, 741 01
Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Czechia
Nemocnice Tomase Bati ve Zline
Zlín, 762 75
Czechia
Rigshospitalet
Copenhagen, 2100
Denmark
Vejle Sygehus
Vejle, 7100
Denmark
Institut de Cancérologie de l'Ouest
Angers, 49055
France
Centre Hospitalier de la Côte Basque
Bayonne, 64109
France
CHU Besançon
Besançon, 25000
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
France
CHRU de Brest
Brest, 29609
France
Centre Oscar Lambret
Lille, 59020
France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
France
Centre Leon Berard
Lyon Cedex08, 69373
France
Institut Régional du Cancer Montpellier
Montpellier, 34298
France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
France
CHU Strasbourg-Hautepierre
Strasbourg, 67098
France
Universitätsklinikum Aachen
Aachen, 52074
Germany
Charité Campus Virchow-Klinikum
Berlin, 13353
Germany
Universitätsklinikum Bonn
Bonn, 53127
Germany
Universitaetsklinikum Koeln
Cologne, 50937
Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
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Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
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Universitaetsklinikum Erlangen
Erlangen, 91054
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Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136
Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Germany
Universitaetsklinikum Ulm
Ulm, 89075
Germany
Alexandra Hospital
Athens, 115 28
Greece
Aretaieio Hospital
Athens, 115 28
Greece
General Hospital of Kalamata
Kalamata, 241 00
Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, 145 64
Greece
Országos Onkológiai Intézet
Budapest, 1122
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
Hungary
Cork University Hospital
Cork, T12 DC4A
Ireland
St. Vincent's University Hospital
Dublin, D04 T6F4
Ireland
St. James's Hospital
Dublin, D08 E9P6
Ireland
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Italy
Ospedale Cannizzaro
Catania, 95126
Italy
Ospedale Vito Fazzi
Lecce, 73100
Italy
Azienda USL 2 Lucca
Lucca, 55100
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Italy
Ospedale Humanitas San Pio X
Milan, 20159
Italy
Azienda Ospedaliero Universitaria
Modena, 41125
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, 59100
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Italy
Hyogo Cancer Center
Akashi, 673-8558
Japan
National Cancer Center Hospital
Chūōku, 104-0045
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298
Japan
Kagoshima University Hospital
Kagoshima, 890-8520
Japan
National Cancer Center Hospital East
Kashiwa, 277-8577
Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
Japan
Nagoya University Hospital
Nagoya, 466-8560
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Gunma Prefectural Cancer Center
Otashi, 373-8550
Japan
Hokkaido University Hospital
Sapporo, 060-8648
Japan
Tohoku University Hospital
Sendai, 980-8574
Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, 028-3695
Japan
The University of Osaka Hospital
Suita, 565-0871
Japan
Ehime University Hospital
Tōon, 791-0295
Japan
Mie University Hospital
Tsu, 514-8507
Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, 03100
Mexico
Higiea Oncologia
Mexico City, 11819
Mexico
INCAN
Mexico City, 14080
Mexico
Unidad Médica Onco-hematológica
Puebla City, 72424
Mexico
Hospital Angeles
Tijuana, 22010
Mexico
University Medical Center Groningen
Groningen, 9713 GZ
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379
Norway
Stavanger Universitetssykehus
Stavanger, 4011
Norway
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
Poznan, 61-866
Poland
Mazowiecki Szpital Wojewódzki w Siedlcach
Siedlce, 08-110
Poland
SC Memorial Healthcare International SRL
Bucharest, 013812
Romania
Sc Mnt Healthcare Europe Srl
Bucharest, 013975
Romania
Institutul Regional de Oncologie
Iași, 700483
Romania
S C Oncocenter Oncologie Clinica S R L
Timișoara, 300166
Romania
Keimyung University Dongsan Hospital
Daegu, 42601
South Korea
National Cancer Center
Goyang-si, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
Hospital Universitari Dexeus
Barcelona, 08028
Spain
Hospital Provincial Centre de Castelló
Castellon, 12002
Spain
Hospital Universitario Virgen Nieves
Granada, 18012
Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702
Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706
Spain
Hospital Universitario de Toledo
Toledo, 45007
Spain
Kantonsspital Baden
Baden, 5404
Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Switzerland
Kantonsspital Graubünden
Chur, 7000
Switzerland
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211
Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301
Taiwan
China Medical University Hospital
Taichung, 404332
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Mackay Memorial Hospital
Taipei, 10449
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Royal United Hospitals NHS Foundation Trust
Bath, BA1 3NG
United Kingdom
St James's University Hospital
Leeds, LS9 7TF
United Kingdom
Royal Marsden Hospital (Sutton)
London, SM2 5PT
United Kingdom
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Torbay Hospital
Torquay, TQ2 7AA
United Kingdom