A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Start Date
2/27/2024
Completion Date
4/30/2030
Summary
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
Detailed Description
This study will focus on R-DXd in participants with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. R-DXd is an antibody-drug conjugate that specifically binds to CDH6, which is overexpressed in tumor cells. The Phase 2 dose-optimization part of the study (Part A) intends to define the recommended dose based on safety and efficacy, while the Phase 3 (Part B) part of the study will compare R-DXd with Investigator's choice of chemotherapy and further evaluate efficacy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
R-DXd
Paclitaxel
Topotecan
PLD
Conditions
Locations
Alaska Women's Cancer Care
Anchorage, Alaska 99508
United States
Yale University School of Medicine
New Haven, Connecticut 06520
United States
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida 33146
United States
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
Florida Cancer Specialists
Lake Mary, Florida 32746
United States
Sylvester Cancer Center
Miami, Florida 33136
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Community MD Anderson Cancer Center- East
Indianapolis, Indiana 46219
United States
Community MD Anderson Cancer Center- South
Indianapolis, Indiana 46227
United States
Community Health Network - MD Anderson
Indianapolis, Indiana 46250
United States
St. Elizabeth Medical Center
Edgewood, Kentucky 41017
United States
Baystate Medical Center
Springfield, Massachusetts 01199-1001
United States
Washington University School of Medicine Obstetrics and Gynecology
St Louis, Missouri 63110
United States
Valley Health System
Paramus, New Jersey 07652
United States
Holy Name
Teaneck, New Jersey 07666
United States
NHPP Imbert
Bay Shore, New York 11706
United States
Northwell Health, LLC PRIME
Lake Success, New York 11042
United States
Perlmutter Cancer Center at NYU Langone Hospital- Long Island
Mineola, New York 11501
United States
NYU Langone Health
New York, New York 10016
United States
NHPP LHH
New York, New York 10065
United States
Duke Women's Cancer Care- Raleigh
Durham, North Carolina 27607
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Ohio State University Wexner Medical Center
Hilliard, Ohio 43026
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma 12967
United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401
United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104-4238
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Sanford Cancer Center Gynecologic Oncology
Sioux Falls, South Dakota 57104
United States
Texas Oncology-Bedford
Bedford, Texas 76022
United States
Houston Area Locations- Woodlands
Conroe, Texas 77384
United States
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas 75231
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United States
Texas Oncology Paris
Fort Worth, Texas 76104
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Texas - MD Anderson
Houston, Texas 77030
United States
Houston Area Locations- Sugar Land
Houston, Texas 77079
United States
Houston Area Locations- West Houston
Houston, Texas 77079
United States
Houston Area Locations- League City
League City, Texas 77573
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
GenesisCare St Andrews Hospital
Adelaide, 5000
Australia
Peter MacCallum Cancer Center
Melbourne, 3000
Australia
Gold Coast University Hospital
Southport, 4215
Australia
GenesisCare North Shore (Oncology)
St Leonards, 2065
Australia
Oncocentro - Belo Horizonte
Belo Horizonte, 30360680
Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90.160-093
Brazil
Hospital Moinhos de Vento
Porto Alegre, 90035-001
Brazil
Instituto COI de Pesquisa
Rio de Janeiro, 22775-001
Brazil
Arthur J. E. Child Comp CC
Calgary, Alberta T2N 5G2
Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, N6A5W9
Canada
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, H4A 3J1
Canada
The Ottawa Hospital Cancer Centre
Ottawa, K1H 8L6
Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, M5G 2M9
Canada
Beijing Cancer Hospital
Beijing, 100142
China
Chongqing Cancer Hospital
Chongqing, 400030
China
Fujian Provincial Cancer Hospital
Fuzhou, 350015
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
Qilu Hospital of Shandong University
Jinan, 250117
China
Shandong Cancer Hospital
Jinan, 250117
China
Guangxi Medical University Cancer Hospital
Nanning, 530021
China
Fudan University Shanghai Cancer Center
Shanghai, 200032
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 453000
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022
China
Hubei Cancer Hospital
Wuhan, 430079
China
Fakultni nemocnice Brno
Brno, 625 00
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Czechia
Fakultni nemocnice v Motole
Prague, 150 06
Czechia
Fakultni nemocnice Bulovka
Prague, 180 81
Czechia
Kuopio University Hospital
Kuopio, 70210
Finland
Institut Bergonié
Bordeaux, 33076
France
Centre Francois Baclesse
Caen, 14076
France
Centre Jean Perrin - CLCC
Clermont-Ferrand, 63000
France
Centre Georges François Leclerc
Dijon, 21079
France
Centre Leon Berard
Lyon, 69008
France
Institut Paoli Calmettes
Marseille, 13273
France
Institut du Cancer de Montpellier
Montpellier, 34298
France
Hôpital Privé du Confluent
Nantes, 44277
France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
Paris, 75571
France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, 22190
France
Institut Curie
Saint-Cloud, 92210
France
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
France
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
Germany
Kliniken Essen-Mitte
Essen, 45136
Germany
Universitaetsklinikum Hamburg-Eppendorf (Ph3)
Hamburg, 20246
Germany
Universitaetsklinikum Mannheim
Mannheim, 68167
Germany
Universitaetsklinikum Ulm
Ulm, 89075
Germany
Aretaieio Hospital
Athens, 11528
Greece
Diagnostic and Therapeutic Centre of Athens "Hygeia" S.A.
Marousi, 15123
Greece
IASO General Clinic
Marousi, 15123
Greece
St Luke's Hospital
Thessaloniki, 55236
Greece
IRCCS Centro di Riferimento Oncologico
Aviano, 33081
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
Italy
Azienda Ospedaliera Per Lemergenza Cannizzaro
Catania, 95126
Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Italy
IEO Istituto Europeo di Oncologia
Milan, 20141
Italy
Humanitas San Pio X
Milan, 20159
Italy
Fondazione IRCCS San Gerardo dei Tintori di Monza
Monza, 20900
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Istituto Clinico Humanitas
Rozzano, 20089
Italy
Ospedale Mauriziano Umberto I
Torino, 10128
Italy
Hyogo Cancer Center
Akashi-shi, 673-8558
Japan
National Cancer Center Hospital
Chūōku, 104-0045
Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
Japan
Jikei University Hospital
Minatoku, 105-8471
Japan
Shizuoka Cancer Center
Nagaizumi-cho, 411-8777
Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Hokkaido University Hospital
Sapporo, 060-8648
Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695
Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 60-569
Poland
Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o
Siedlce, 08-110
Poland
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, 2720-276
Portugal
Fundação Champalimaud
Lisbon, 1400-038
Portugal
Hospital da Luz
Lisbon, 1500-650
Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Portugal
National Cancer Center
Goyang-si, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System - Site 8201
Seoul, 03722
South Korea
Severance Hospital, Yonsei University Health System - Site 8207
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Samsung Medical Center
Seoul,
South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Spain
Hospital Universitario Ciudad de Jaen
Jaén, 23007
Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Clinica Universidad de Navarra (MAD)
Pamplona, 31008
Spain
Clinica Universidad de Navarra
Pamplona, 31008
Spain
Hospital Clínico Universitario Valencia
Valencia, 46010
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
National Cheng Kung University Hospital
Tainan, 70403
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan City, 333
Taiwan
Baskent University Adana Application and Research Center
Adana, 01240
Turkey (Türkiye)
Cukurova University Medical Faculty
Adana, 01790
Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
Turkey (Türkiye)
I. U. Cerrahpasa Faculty of Med
Istanbul, 34153
Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34214
Turkey (Türkiye)
Royal United Hospital
Bath, BA1 3NG
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United Kingdom
Churchill Hospital
Headington, OX3 7LE
United Kingdom
University College London Hospitals
London, NW1 2PG
United Kingdom
Northampton General Hospital (Ph3)
Northampton, NN1 5BD
United Kingdom