AzTrials
AzTrials

Solid CancerPhase 2/3NCT06161025

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2/3 study testing R-DXd, Paclitaxel and Topotecan in people with Solid Cancer, run by Daiichi Sankyo at 167 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Cancer
What is being tested?
R-DXd, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
860 participants
Where
167 sitesin 19 countries
Study dates
27 Feb 2024to 30 Apr 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
  • Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
  • Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.
  • For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen.
  • For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy:
  • Neoadjuvant +/-adjuvant considered 1 line of therapy.
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  • Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors) will be considered part of the preceding line of therapy.
  • Therapy changed due to toxicity in the absence of progression will be considered part of the same line.
  • Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.
  • At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance. Note: Subjects must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.
  • Has platinum-resistant disease. If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between >90 and ≤180 days after the date of the last dose of platinum If a subject had 2 or 4 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum.
  • If mirvetuximab soravtansine (MIRV) is locally available: Has had prior treatment with MIRV for participants with documented high-folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally.
  • Has at least 1 measurable lesion evaluated by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per investigator assessment.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Has adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration).
  • Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.
  • For Phase 3 (Part B) only: Subjects must be eligible for one of the treatments included in the investigator's choice of chemotherapy arm.

Who cannot join

  • Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 [Part B]: seromucinous, low-grade serous carcinoma or ovarian sarcoma, carcinosarcoma and undifferentiated carcinoma are excluded.)
  • Inadequate washout period before Cycle 1 Day 1, defined as follows:
  • Major surgery <28 days
  • Radiation therapy <28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
  • Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting study drug
  • Chloroquine/hydroxychloroquine <14 days
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  • Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures
  • Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion A minimum of 2 weeks must have elapsed between the end of radiotherapy and randomization and there should be no evidence of progression or need for steroid treatment or anticonvulsants for at least 2 weeks prior to randomization. Note: If there is a history or suspicion of central nervous system. Note: If there is a history or suspicion of central nervous system metastasis, a CT scan of the head or MRI of the brain must be performed at baseline.
  • Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
  • Uncontrolled or significant cardiovascular disease, including the following:
  • QT interval corrected with Fridericia's formula interval >470 ms.
  • Diagnosed or suspected long QT syndrome.
  • History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
  • The participant has bradycardia of less than 50 bpm, unless the subject has a pacemaker.
  • History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
  • Myocardial infarction within 6 months prior to screening.
  • Uncontrolled angina pectoris within 6 months prior to screening.
  • New York Heart Association Class 3 or 4 congestive heart failure.
  • Left ventricular ejection fraction <50% or institutional lower limit of normal as measured by echocardiography or multigated acquisition (MUGA) scan.
  • Coronary/peripheral artery bypass graft within 6 months prior to screening
  • Uncontrolled hypertension (HgCTCAE Grade ≥3 hypertension as per NCI-CTCAE version 5.0).
  • Complete left or right bundle branch block.
  • Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy.
  • Chronic steroid treatment (>10 mg/day), with the exception of the following:
  • Inhaled steroids for asthma or COPD
  • Mineralocorticoids (eg, fludrocortisone) for subjects with orthostatic hypotension
  • Topical steroids for mild skin conditions
  • Low-dose supplemental corticosteroids for adrenocortical insufficiency
  • Premedication for treatment groups and/or premedication in case of any hypersensitivity
  • Intra-articular steroid injections
  • History of malignancy other than epithelial OVC, primary peritoneal cancer, or fallopian tube cancer within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate >90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage 1 uterine cancer).
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade >2 for 3 months prior to randomization and managed with SOC treatment) that the investigator deems related to previous anticancer therapy, following discussion with the Sponsor, such as the following:
  • Chemotherapy-induced neuropathy
  • Fatigue
  • Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency
  • Skin pigmentation (vitiligo)
  • For Phase 2 (Part A): Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan or datopotamab deruxtecan). For Phase 3 (Part B): Prior exposure to other CDH6-targeted agents or an antibody-drug conjugate containing a topoisomerase I inhibitor.
  • History of hypersensitivity to any excipients in the R-DXd or any known contraindication to treatment with, including hypersensitivity to, the study drug(s).
  • Has an active or uncontrolled human immunodeficiency virus (HIV) infection.
  • Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the investigator's opinion, makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.
  • Has an active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Hepatitis B and Hepatitis C Screening tests are required.
  • Subjects are eligible if:
  • Hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
  • History of hepatitis C infection: eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.
  • Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT <3 × ULN, which are not attributable to HCV infection.
  • Female who is pregnant or breastfeeding or intends to become pregnant during the study.
  • Psychological, social, familial, or geographical factors that would prevent regular follow-up.
  • Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.
  • Has a history of receiving live-attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention.
  • For Phase 3 (Part B) only: Has clinical symptoms or radiographic evidence of intestinal obstruction.
  • For Phase 3 (Part B) only: Has ascites or pleural effusions that require repeated drainage (less than 4 weeks between drainages).

Trial locations and contacts

167 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Medical Director Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

167 sites in 19 countries

United States45 sites, 27 recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Recruiting

  • NHPP Imbert

    Bay Shore, New York, 11706

    Active, not recruiting

  • Texas Oncology-Bedford

    Bedford, Texas, 76022

    Active, not recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Recruiting

  • Houston Area Locations- Woodlands

    Conroe, Texas, 77384

    Active, not recruiting

  • Sylvester Comprehensive Cancer Center at Lennar

    Coral Gables, Florida, 33146

    Active, not recruiting

  • Texas Oncology-Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

    Active, not recruiting

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Active, not recruiting

  • Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Active, not recruiting

  • Duke Women's Cancer Care- Raleigh

    Durham, North Carolina, 27607

    Active, not recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

    Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

    Recruiting

  • Texas Oncology Paris

    Fort Worth, Texas, 76104

    Recruiting

  • Ohio State University Wexner Medical Center

    Hilliard, Ohio, 43026

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Recruiting

  • University of Texas - MD Anderson

    Houston, Texas, 77030

    Recruiting

  • Houston Area Locations- Sugar Land

    Houston, Texas, 77079

    Active, not recruiting

  • Houston Area Locations- West Houston

    Houston, Texas, 77079

    Active, not recruiting

  • Community MD Anderson Cancer Center- East

    Indianapolis, Indiana, 46219

    Active, not recruiting

  • Community MD Anderson Cancer Center- South

    Indianapolis, Indiana, 46227

    Active, not recruiting

  • Community Health Network - MD Anderson

    Indianapolis, Indiana, 46250

    Recruiting

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

    Recruiting

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746

    Recruiting

  • Northwell Health, LLC PRIME

    Lake Success, New York, 11042

    Recruiting

  • Houston Area Locations- League City

    League City, Texas, 77573

    Active, not recruiting

  • Sylvester Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Recruiting

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital- Long Island

    Mineola, New York, 11501

    Active, not recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • NHPP LHH

    New York, New York, 10065

    Active, not recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Valley Health System

    Paramus, New Jersey, 07652

    Recruiting

  • Perelman School of Medicine at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4238

    Recruiting

  • Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Active, not recruiting

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

    Recruiting

  • Sanford Cancer Center Gynecologic Oncology

    Sioux Falls, South Dakota, 57104

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199-1001

    Active, not recruiting

  • Washington University School of Medicine Obstetrics and Gynecology

    St Louis, Missouri, 63110

    Recruiting

  • Holy Name

    Teaneck, New Jersey, 07666

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 12967

    Recruiting

Other trials in United States

Japan14 sites

  • Hyogo Cancer Center

    Akashi-shi, 673-8558

    Active, not recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    Active, not recruiting

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

    Active, not recruiting

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298

    Active, not recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577

    Active, not recruiting

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    Active, not recruiting

  • Jikei University Hospital

    Minatoku, 105-8471

    Active, not recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, 411-8777

    Active, not recruiting

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

    Active, not recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Active, not recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Active, not recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Active, not recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    Active, not recruiting

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

    Active, not recruiting

Other trials in Japan

China13 sites, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Active, not recruiting

  • Chongqing Cancer Hospital

    Chongqing, 400030

    Active, not recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, 350015

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

    Active, not recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Active, not recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250117

    Active, not recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Active, not recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, 530021

    Active, not recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Active, not recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 453000

    Active, not recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

    Active, not recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Active, not recruiting

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi’an, Shanxi, 710061

    Recruiting

Other trials in China

France12 sites

  • Institut Bergonié

    Bordeaux, 33076

    Active, not recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Active, not recruiting

  • Centre Jean Perrin - CLCC

    Clermont-Ferrand, 63000

    Active, not recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Active, not recruiting

  • Centre Leon Berard

    Lyon, 69008

    Active, not recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Active, not recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34298

    Active, not recruiting

  • Hôpital Privé du Confluent

    Nantes, 44277

    Active, not recruiting

  • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon

    Paris, 75571

    Active, not recruiting

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin, 22190

    Active, not recruiting

  • Institut Curie

    Saint-Cloud, 92210

    Active, not recruiting

  • ICL Alexis Vautrin

    Vandœuvre-lès-Nancy, 54500

    Active, not recruiting

Other trials in France

Italy11 sites

  • IRCCS Centro di Riferimento Oncologico

    Aviano, 33081

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138

    Active, not recruiting

  • Azienda Ospedaliera Per Lemergenza Cannizzaro

    Catania, 95126

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    Active, not recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

    Active, not recruiting

  • Humanitas San Pio X

    Milan, 20159

    Active, not recruiting

  • Fondazione IRCCS San Gerardo dei Tintori di Monza

    Monza, 20900

    Active, not recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

    Active, not recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

    Active, not recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Completed

  • Ospedale Mauriziano Umberto I

    Torino, 10128

    Active, not recruiting

Other trials in Italy

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Active, not recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

    Completed

  • Hospital Universitario Ciudad de Jaen

    Jaén, 23007

    Active, not recruiting

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Active, not recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Active, not recruiting

  • Clinica Universidad de Navarra (MAD)

    Pamplona, 31008

    Active, not recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Active, not recruiting

  • Hospital Clínico Universitario Valencia

    Valencia, 46010

    Active, not recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Active, not recruiting

Other trials in Spain

South Korea9 sites

  • National Cancer Center

    Goyang-si, 10408

    Active, not recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Active, not recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System - Site 8201

    Seoul, 03722

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System - Site 8207

    Seoul, 03722

    Active, not recruiting

  • Asan Medical Center

    Seoul, 05505

    Active, not recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

    Active, not recruiting

  • Samsung Medical Center

    Seoul

    Active, not recruiting

Other trials in South Korea

Taiwan6 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Active, not recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

    Active, not recruiting

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan City, 333

    Active, not recruiting

Other trials in Taiwan

Canada5 sites

  • Arthur J. E. Child Comp CC

    Calgary, Alberta, T2N 5G2

    Active, not recruiting

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    London, N6A5W9

    Active, not recruiting

  • McGill University Health Centre/Glen Site / Royal Victoria Hospital

    Montreal, H4A 3J1

    Active, not recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6

    Active, not recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, M5G 2M9

    Active, not recruiting

Other trials in Canada

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

    Active, not recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

    Active, not recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

    Active, not recruiting

  • Fakultni nemocnice v Motole

    Prague, 150 06

    Active, not recruiting

  • Fakultni nemocnice Bulovka

    Prague, 180 81

    Active, not recruiting

Other trials in Czechia

Germany5 sites

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

    Active, not recruiting

  • Kliniken Essen-Mitte

    Essen, 45136

    Active, not recruiting

  • Universitaetsklinikum Hamburg-Eppendorf (Ph3)

    Hamburg, 20246

    Active, not recruiting

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

    Active, not recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89075

    Active, not recruiting

Other trials in Germany

Turkey (Türkiye)5 sites

  • Baskent University Adana Application and Research Center

    Adana, 01240

    Active, not recruiting

  • Cukurova University Medical Faculty

    Adana, 01790

    Active, not recruiting

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

    Active, not recruiting

  • I. U. Cerrahpasa Faculty of Med

    Istanbul, 34153

    Active, not recruiting

  • Medipol University Medical Faculty

    Istanbul, 34214

    Active, not recruiting

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • Royal United Hospital

    Bath, BA1 3NG

    Active, not recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Active, not recruiting

  • Churchill Hospital

    Headington, OX3 7LE

    Active, not recruiting

  • University College London Hospitals

    London, NW1 2PG

    Active, not recruiting

  • Northampton General Hospital (Ph3)

    Northampton, NN1 5BD

    Active, not recruiting

Other trials in United Kingdom

Australia4 sites

  • GenesisCare St Andrews Hospital

    Adelaide, 5000

    Active, not recruiting

  • Peter MacCallum Cancer Center

    Melbourne, 3000

    Active, not recruiting

  • Gold Coast University Hospital

    Southport, 4215

    Active, not recruiting

  • GenesisCare North Shore (Oncology)

    St Leonards, 2065

    Active, not recruiting

Other trials in Australia

Brazil4 sites, 1 recruiting

  • Oncocentro - Belo Horizonte

    Belo Horizonte, 30360680

    Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, 90.160-093

    Active, not recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Active, not recruiting

  • Instituto COI de Pesquisa

    Rio de Janeiro, 22775-001

    Active, not recruiting

Other trials in Brazil

Greece4 sites

  • Aretaieio Hospital

    Athens, 11528

    Active, not recruiting

  • Diagnostic and Therapeutic Centre of Athens "Hygeia" S.A.

    Marousi, 15123

    Active, not recruiting

  • IASO General Clinic

    Marousi, 15123

    Active, not recruiting

  • St Luke's Hospital

    Thessaloniki, 55236

    Active, not recruiting

Other trials in Greece

Poland4 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

    Active, not recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 60-569

    Active, not recruiting

  • Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o

    Siedlce, 08-110

    Active, not recruiting

Other trials in Poland

Portugal4 sites

  • Hospital Professor Doutor Fernando Fonseca, E.P.E.

    Amadora, 2720-276

    Active, not recruiting

  • Fundação Champalimaud

    Lisbon, 1400-038

    Active, not recruiting

  • Hospital da Luz

    Lisbon, 1500-650

    Active, not recruiting

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

    Active, not recruiting

Other trials in Portugal

Finland1 site

  • Kuopio University Hospital

    Kuopio, 70210

    Active, not recruiting

Other trials in Finland

About this study

Official title: A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Read the 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.

Conditions
Solid Cancer
Being tested
R-DXd, Paclitaxel, Topotecan, PLD
Keywords
Primary pertioneal cancer, Ovarian cancer, Fallopian tube cancer, Raludotatug Deruxtecan (R-DXd), Cadherin 6 (CDH6)
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-DXdDrug

    Also called DS-6000a

    R-DXd will be administered as an intravenously (IV) infusion

  • PaclitaxelDrug

    Paclitaxel will be administered as an IV infusion

  • TopotecanDrug

    Topotecan will be administered as an IV infusion

  • PLDDrug

    Also called Pegylated Liposomal Doxorubicin

    PLD will be administered as an IV infusion

Study groups in NCT06161025
Study groupRoleWhat they receive
Part A: R-DXd 4.8mg/kg Q3WExperimentalParticipants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).
Receives: Drug: R-DXd
Part A: R-DXd 5.6 mg/kg Q3WExperimentalParticipants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).
Receives: Drug: R-DXd
Part A: R-DXd 6.4 mg/kg Q3WExperimentalParticipants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
Receives: Drug: R-DXd
Part B: R-DXd RP3D Q3WExperimentalParticipants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).
Receives: Drug: R-DXd
Part B: Investigator's ChoiceActive comparatorParticipants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan.
Receives: Drug: Paclitaxel; Drug: Topotecan; Drug: PLD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)

    The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.

    Measured: From date of randomization to data cut off, up to 18 months

  2. Progression-free Survival (PFS) Based on BICR Assessment (Part B)

    PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.

    Measured: From date of randomization to data cut off, up to 26 months

Secondary outcomes (21)

  1. Objective Response Rate (ORR) Based on Investigator Assessment

    The ORR was defined as the percentage of participants who achieved Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), by Investigator assessment based on RECIST version 1.1.

    Measured: From date of randomization to data cut off, up to 30 months

  2. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: From date of randomization to data cut off, up to 40 months

  3. Duration of Response (DOR)

    DoR is defined as the time from the date of the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: From date of randomization to data cut off, up to 40 months

  4. Progression-free Survival (PFS) Based on BICR and Investigator Assessment

    PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause.

    Measured: From date of randomization to data cut off, up to 30 months

  5. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants who achieved a confirmed CR, PR, or stable disease maintained for ≥12 weeks, as assessed by BICR and investigator based on RECIST version 1.1

    Measured: From date of randomization to data cut off, up to 40 months

  6. Time to Next Treatment (TTNT)

    TTNT is defined as the time from randomization to the start date of the next line of therapy

    Measured: From date of randomization to data cut off, up to 40 months

  7. Progression-free Survival 2 (PFS2) Based on Investigator Assessment

    PFS2 is defined as the time from randomization to the first documented objective disease progression on next line therapy or death due to any cause, whichever comes first.

    Measured: From date of randomization to data cut off, up to 40 months

  8. Percentage of Participants With Cancer Antigen 125 (CA-125) Response Rate

    CA-125 response rate is defined as the percentage of participants with a reduction of 50% in CA-125 levels when compared to levels from a pretreatment sample, as assessed by blood sample based on Gynecological Cancer InterGroup criteria

    Measured: From baseline to data cut off, up to 40 months

  9. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    TEAEs are defined as those AEs with a start or worsening date during the on-treatment period (from the first dose date to 40 days after the last dose date of study treatment).

    Measured: From first dose to data cut off, up to 40 months

  10. Pharmacokinetic (PK) Analysis: Maximum Plasma Drug Concentration (Cmax) of R-DXd

    Measured: From first dose to data cut off, up to 40 months

  11. Pharmacokinetic (PK) Analysis: Time to Reach Maximum Plasma Drug Concentration (Tmax) of R-DXP

    Measured: From first dose to data cut off, up to 40 months

  12. Pharmacokinetic (PK) Analysis: Area Under the Concentration-Time Curve (AUC) of R-DXd

    Measured: From first dose to data cut off, up to 40 months

  13. Percentage of Participants With Treatment Emergent Antidrug Antibody (ADA)

    Measured: From baseline to data cut off, up to 40 months

  14. Pharmacokinetic (PK) Analysis: Terminal Half-Life (t1/2) of R-DXd

    Measured: From first dose to data cut off, up to 40 months

  15. Change from Baseline in Abdominal/gastrointestinal (GI) Symptoms (Part B)

    Change from baseline in abdominal and gastrointestinal symptoms as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) OV28 abdominal/GI subscale

    Measured: From baseline to Week 12 and up to data cut off, up to 40 months

  16. Change from Baseline in Fatigue/Pain Symptoms (Part B)

    Change from baseline as measured by the EORTC QLQ C30 Fatigue/Pain subscale score

    Measured: From baseline to data cut off, up to 40 months

  17. Time to Deterioration in Fatigue/Pain Symptoms (Part B)

    Time to deterioration in pain from baseline as measured by the EORTC QLQ C30 Fatigue/Pain subscale score

    Measured: From baseline to data cut off, up to 40 months

  18. Time to Deterioration in GI Symptoms (Part B)

    Time to deterioration in pain from baseline as measured by the EORTC QLQ OV28 abdominal/GI subscale total score

    Measured: From baseline to data cut off, up to 40 months

  19. Time to Deterioration in Disease Impacts (Part B)

    Time to deterioration in selected subscales of EORTC QLQ C30; physical functioning, global health status, overall quality of life.

    Measured: From baseline to data cut off, up to 40 months

  20. Change from Baseline in Disease Impacts (Part B)

    Change from Baseline in selected subscales of EORTC QLQ C30; physical functioning, global health status, overall quality of life.

    Measured: From baseline to data cut off, up to 40 months

  21. Cadherin-6 (CDH6) protein expression in tumor tissue as determined by immunochemistry assay and correlation with ORR, DoR, PFS and OS

    CDH6 protein expression in tumor tissue as determined by immunohistochemistry.

    Measured: From baseline to data cut off, up to 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2023
  2. Study start27 Feb 2024
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161025
Sponsor's protocol ID
DS6000-109
Other IDs
REJOICE-Ovarian01, ENGOT-ov77, GOG-3096, jRCT2031230556
Status last verified
Jul 2026
First submitted
27 Nov 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing R-DXd, Paclitaxel and Topotecan in people with Solid Cancer, run by Daiichi Sankyo at 167 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Japan, China, France, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Director Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A) (time frame: From date of randomization to data cut off, up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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