RecruitingPhase 2Phase 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, 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


Sponsor

Daiichi Sankyo

Enrollment

860 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new antibody-drug treatment called raludotatug deruxtecan (R-DXd) in women with advanced ovarian, fallopian tube, or peritoneal cancer whose cancer has come back or stopped responding to platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older - You have high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - Your cancer is platinum-resistant (stopped responding to platinum chemo) - You have received 1–4 prior lines of treatment (depending on study phase) - You have a tumor that can be biopsied - Your organ function (kidneys, liver, blood) meets required thresholds **You may NOT be eligible if...** - You have received prior treatment with a CDH6-targeting therapy - You have symptomatic or untreated brain metastases - You have serious interstitial lung disease - You are pregnant or breastfeeding - You have uncontrolled infections or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-DXd

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

DRUGPaclitaxel

Paclitaxel will be administered as an IV infusion

DRUGTopotecan

Topotecan will be administered as an IV infusion

DRUGPLD

PLD will be administered as an IV infusion


Locations(120)

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Sylvester Comprehensive Cancer Center at Lennar

Coral Gables, Florida, United States

Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Community MD Anderson Cancer Center- East

Indianapolis, Indiana, United States

Community MD Anderson Cancer Center- South

Indianapolis, Indiana, United States

Community Health Network - MD Anderson

Indianapolis, Indiana, United States

St. Elizabeth Medical Center

Edgewood, Kentucky, United States

Washington University School of Medicine Obstetrics and Gynecology

St Louis, Missouri, United States

Valley Health System

Paramus, New Jersey, United States

Holy Name

Teaneck, New Jersey, United States

NHPP Imbert

Bay Shore, New York, United States

Northwell Health, LLC PRIME

Lake Success, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital- Long Island

Mineola, New York, United States

NYU Langone Health

New York, New York, United States

NHPP LHH

New York, New York, United States

Duke Women's Cancer Care- Raleigh

Durham, North Carolina, United States

Duke Cancer Center

Durham, North Carolina, United States

Ohio State University Wexner Medical Center

Hilliard, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Sanford Cancer Center Gynecologic Oncology

Sioux Falls, South Dakota, United States

Texas Oncology-Bedford

Bedford, Texas, United States

Houston Area Locations- Woodlands

Conroe, Texas, United States

Texas Oncology-Presbyterian Cancer Center Dallas

Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology Paris

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Texas - MD Anderson

Houston, Texas, United States

Houston Area Locations- Sugar Land

Houston, Texas, United States

Houston Area Locations- West Houston

Houston, Texas, United States

Houston Area Locations- League City

League City, Texas, United States

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, United States

GenesisCare St Andrews Hospital

Adelaide, Australia

GenesisCare North Shore (Oncology)

St Leonards, Australia

McGill University Health Centre/Glen Site / Royal Victoria Hospital

Montreal, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Canada

Beijing Cancer Hospital

Beijing, China

Chongqing Cancer Hospital

Chongqing, China

Fujian Provincial Cancer Hospital

Fuzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Shandong Cancer Hospital

Jinan, China

Qilu Hospital of Shandong University

Jinan, China

Guangxi Medical University Cancer Hospital

Nanning, China

Fudan University Shanghai Cancer Center

Shanghai, China

National Cheng Kung University Hospital

Tainan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

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

Wuhan, China

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Fakultni nemocnice Bulovka

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Institut Bergonié

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Jean Perrin - CLCC

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Institut du Cancer de Montpellier

Montpellier, France

Hôpital Privé du Confluent

Nantes, France

Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon

Paris, France

CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

Plérin, France

Institut Curie

Saint-Cloud, France

ICL Alexis Vautrin

Vandœuvre-lès-Nancy, France

Kliniken Essen-Mitte

Essen, Germany

Universitaetsklinikum Mannheim

Mannheim, Germany

Universitaetsklinikum Ulm

Ulm, Germany

IRCCS Centro di Riferimento Oncologico

Aviano, Italy

Azienda Ospedaliera Per Lemergenza Cannizzaro

Catania, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Humanitas San Pio X

Milan, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Ospedale Mauriziano Umberto I

Torino, Italy

National Cancer Center Hospital

Chūōku, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Jikei University Hospital

Minatoku, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka International Cancer Institute

Osaka, Japan

Hokkaido University Hospital

Sapporo, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o

Siedlce, Poland

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

Amadora, Portugal

National Cancer Center

Goyang-si, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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

Seoul, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Ciudad de Jaen

Jaén, Spain

Hospital Universitario Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Clinica Universidad de Navarra (MAD)

Pamplona, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Clínico Universitario Valencia

Valencia, Spain

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Chang Gung Memorial Hospital,Linkou

Taoyuan City, Taiwan

Royal United Hospital

Bath, United Kingdom

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NCT06161025


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