Actively Recruiting
A Phase 2/3 Randomized Study of Raludotatug Deruxtecan (R-DXd) in Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by Daiichi Sankyo · Updated on 2026-05-22
860
Participants Needed
146
Research Sites
113 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This study includes both Phase 2 and Phase 3 parts, aiming to determine the best dose of R-DXd and compare it with standard chemotherapy treatments. R-DXd is designed to target CDH6, a protein found in high amounts on tumor cells, to deliver its treatment directly to the cancer. Participants will be randomly assigned to receive intravenous R-DXd at different doses every three weeks or to receive chemotherapy chosen by the doctor, including paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. The Phase 2 part focuses on finding the recommended dose based on safety and response, while Phase 3 compares R-DXd at the recommended dose against chemotherapy to further assess its effects. Throughout the study, participants will undergo scans to measure tumor response and various assessments to monitor symptoms, side effects, and other health factors. Researchers will track outcomes like tumor shrinkage, survival without disease progression, overall survival, treatment side effects, and quality of life measures for up to 40 months. Participants will have regular visits for treatment, lab tests, and symptom evaluations to ensure close monitoring during the trial.
CONDITIONS
Brief Title
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- For Phase 2: At least 1 lesion suitable for biopsy and willing to provide tissue samples (pretreatment and on-treatment biopsies)
- For Phase 3: Eligible for investigator's choice of chemotherapy
- Received 1 to 3 prior systemic anticancer therapies for Phase 2; 1 to 4 for Phase 3
- At least 1 prior therapy containing bevacizumab unless not eligible
- Platinum-resistant disease as defined by progression within specified time after platinum therapy
- At least 1 measurable lesion by CT or MRI per RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function based on lab tests
- Willing and able to comply with study visits, drug administration, tests, and procedures
You will not qualify if you...
- Clear cell, mucinous, sarcomatous, mixed histology tumors, or low-grade/borderline ovarian cancer
- Inadequate washout period from prior surgery, radiation, anticancer therapy, or investigational drugs
- Active or symptomatic brain metastases or spinal cord compression requiring treatment
- Cerebrovascular events or arterial thromboembolism within past 6 months
- Significant uncontrolled cardiovascular disease including long QT syndrome, arrhythmias, recent myocardial infarction, heart failure class 3 or 4, or uncontrolled hypertension
- History or current interstitial lung disease or pneumonitis requiring corticosteroids
- Severe pulmonary compromise or prior pneumonectomy
- Chronic steroid treatment above 10 mg/day except certain exceptions
- History of other malignancies within 3 years except low-risk treated cancers
- Unresolved toxicities from prior anticancer therapy beyond grade 1 except stable grade 2 toxicities
- Prior exposure to other CDH6-targeted agents or related antibody-drug conjugates
- Hypersensitivity to study drugs or excipients
- Active or uncontrolled HIV, hepatitis B or C infections
- Pregnant or breastfeeding females
- Psychological, social, or geographic factors preventing follow-up
- Prior live-attenuated vaccine within 30 days
- For Phase 3 only: Intestinal obstruction or frequent ascites/pleural drainage needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 months or until disease progression or discontinuation
Participants receive intravenous infusions of either R-DXd or investigator's choice of chemotherapy every 3 weeks.
Infusions every 3 weeks
Duration - Up to 40 months from first dose
Participants are monitored for safety, disease progression, and survival after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 146 locations
1
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida, United States, 33146
Active, Not Recruiting
4
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Active, Not Recruiting
5
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Actively Recruiting
6
Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
8
Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Active, Not Recruiting
9
Community MD Anderson Cancer Center- East
Indianapolis, Indiana, United States, 46219
Active, Not Recruiting
10
Community MD Anderson Cancer Center- South
Indianapolis, Indiana, United States, 46227
Active, Not Recruiting
11
Community Health Network - MD Anderson
Indianapolis, Indiana, United States, 46250
Actively Recruiting
12
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Actively Recruiting
13
Baystate Medical Center
Springfield, Massachusetts, United States, 01199-1001
Actively Recruiting
14
Washington University School of Medicine Obstetrics and Gynecology
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Valley Health System
Paramus, New Jersey, United States, 07652
Actively Recruiting
16
Holy Name
Teaneck, New Jersey, United States, 07666
Actively Recruiting
17
NHPP Imbert
Bay Shore, New York, United States, 11706
Active, Not Recruiting
18
Northwell Health, LLC PRIME
Lake Success, New York, United States, 11042
Actively Recruiting
19
Perlmutter Cancer Center at NYU Langone Hospital- Long Island
Mineola, New York, United States, 11501
Active, Not Recruiting
20
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
21
NHPP LHH
New York, New York, United States, 10065
Active, Not Recruiting
22
Duke Women's Cancer Care- Raleigh
Durham, North Carolina, United States, 27607
Active, Not Recruiting
23
Duke Cancer Center
Durham, North Carolina, United States, 27710
Active, Not Recruiting
24
Ohio State University Wexner Medical Center
Hilliard, Ohio, United States, 43026
Actively Recruiting
25
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
26
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States, 12967
Actively Recruiting
27
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
28
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4238
Actively Recruiting
29
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
30
Sanford Cancer Center Gynecologic Oncology
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
31
Texas Oncology-Bedford
Bedford, Texas, United States, 76022
Active, Not Recruiting
32
Houston Area Locations- Woodlands
Conroe, Texas, United States, 77384
Active, Not Recruiting
33
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas, United States, 75231
Active, Not Recruiting
34
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Active, Not Recruiting
35
Texas Oncology Paris
Fort Worth, Texas, United States, 76104
Actively Recruiting
36
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
37
University of Texas - MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
38
Houston Area Locations- Sugar Land
Houston, Texas, United States, 77079
Active, Not Recruiting
39
Houston Area Locations- West Houston
Houston, Texas, United States, 77079
Active, Not Recruiting
40
Houston Area Locations- League City
League City, Texas, United States, 77573
Active, Not Recruiting
41
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
42
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
43
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
44
GenesisCare St Andrews Hospital
Adelaide, Australia, 5000
Actively Recruiting
45
GenesisCare North Shore (Oncology)
St Leonards, Australia
Actively Recruiting
46
Oncocentro - Belo Horizonte
Belo Horizonte, Brazil, 30360680
Actively Recruiting
47
Hospital Ernesto Dornelles
Porto Alegre, Brazil, 90.160-093
Actively Recruiting
48
Hospital Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Actively Recruiting
49
Instituto COI de Pesquisa
Rio de Janeiro, Brazil, 22775-001
Actively Recruiting
50
Arthur J. E. Child Comp CC
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
51
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, Canada
Actively Recruiting
52
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
Active, Not Recruiting
53
Beijing Cancer Hospital
Beijing, China
Active, Not Recruiting
54
Chongqing Cancer Hospital
Chongqing, China, 400030
Active, Not Recruiting
55
Fujian Provincial Cancer Hospital
Fuzhou, China, 350015
Active, Not Recruiting
56
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Active, Not Recruiting
57
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Active, Not Recruiting
58
Shandong Cancer Hospital
Jinan, China, 250117
Active, Not Recruiting
59
Qilu Hospital of Shandong University
Jinan, China
Active, Not Recruiting
60
Guangxi Medical University Cancer Hospital
Nanning, China
Active, Not Recruiting
61
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Active, Not Recruiting
62
National Cheng Kung University Hospital
Tainan, China
Actively Recruiting
63
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Active, Not Recruiting
64
Hubei Cancer Hospital
Wuhan, China, 430079
Active, Not Recruiting
65
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Active, Not Recruiting
66
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
67
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 50005
Actively Recruiting
68
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Actively Recruiting
69
Fakultni nemocnice Bulovka
Prague, Czechia
Actively Recruiting
70
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Actively Recruiting
71
Kuopio University Hospital
Kuopio, Finland, 70210
Actively Recruiting
72
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
73
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
74
Centre Jean Perrin - CLCC
Clermont-Ferrand, France, 63000
Actively Recruiting
75
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
76
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
77
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
78
Institut du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
79
Hôpital Privé du Confluent
Nantes, France, 44277
Actively Recruiting
80
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
Paris, France, 75571
Actively Recruiting
81
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, France, 22190
Actively Recruiting
82
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
83
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
84
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany, 01307
Actively Recruiting
85
Kliniken Essen-Mitte
Essen, Germany, 45136
Actively Recruiting
86
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
87
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Actively Recruiting
88
Diagnostic and Therapeutic Centre of Athens "Hygeia" S.A.
Marousi, Greece, 15123
Actively Recruiting
89
IASO General Clinic
Marousi, Greece, 15123
Actively Recruiting
90
St Luke's Hospital
Thessaloniki, Greece, 55236
Actively Recruiting
91
IRCCS Centro di Riferimento Oncologico
Aviano, Italy
Actively Recruiting
92
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy, 40138
Actively Recruiting
93
Azienda Ospedaliera Per Lemergenza Cannizzaro
Catania, Italy
Active, Not Recruiting
94
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Actively Recruiting
95
Humanitas San Pio X
Milan, Italy
Actively Recruiting
96
IEO Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
97
Fondazione IRCCS San Gerardo dei Tintori di Monza
Monza, Italy, 20900
Actively Recruiting
98
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Actively Recruiting
99
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
100
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Completed
101
Ospedale Mauriziano Umberto I
Torino, Italy
Actively Recruiting
102
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
103
NHO Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
104
Saitama Medical University International Medical Center
Hidaka-shi, Japan, 350-1298
Actively Recruiting
105
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Actively Recruiting
106
Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
107
Jikei University Hospital
Minatoku, Japan, 105-8471
Active, Not Recruiting
108
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Actively Recruiting
109
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
110
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Actively Recruiting
111
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
112
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Actively Recruiting
113
Iwate Medical University Hospital
Shiwa-gun, Japan, 028-3695
Actively Recruiting
114
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-276
Actively Recruiting
115
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Actively Recruiting
116
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland, 60-569
Actively Recruiting
117
Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o
Siedlce, Poland
Actively Recruiting
118
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, Portugal
Actively Recruiting
119
Hospital da Luz
Lisbon, Portugal, 1500-650
Actively Recruiting
120
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
121
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Actively Recruiting
122
National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
123
Severance Hospital, Yonsei University Health System - Site 8201
Seoul, South Korea, 03722
Actively Recruiting
124
Severance Hospital, Yonsei University Health System - Site 8207
Seoul, South Korea, 03722
Actively Recruiting
125
Asan Medical Center
Seoul, South Korea
Actively Recruiting
126
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
127
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
128
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
129
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
130
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
131
Hospital Universitario Ciudad de Jaen
Jaén, Spain
Active, Not Recruiting
132
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
133
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
134
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
135
Clinica Universidad de Navarra (MAD)
Pamplona, Spain
Active, Not Recruiting
136
Clinica Universidad de Navarra
Pamplona, Spain
Active, Not Recruiting
137
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
138
Hospital Clínico Universitario Valencia
Valencia, Spain
Actively Recruiting
139
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
140
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
141
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Actively Recruiting
142
Chang Gung Memorial Hospital,Linkou
Taoyuan City, Taiwan
Actively Recruiting
143
Baskent University Adana Application and Research Center
Adana, Turkey (Türkiye), 01240
Actively Recruiting
144
I. U. Cerrahpasa Faculty of Med
Istanbul, Turkey (Türkiye), 34153
Actively Recruiting
145
Medipol University Medical Faculty
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
146
Royal United Hospital
Bath, United Kingdom
Active, Not Recruiting
Research Team
M
Medical Director Contact for Clinical Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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