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NCT07213804PHASE3Recruiting

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

Eli Lilly and Company

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

Inclusion Criteria: Part A, B, and C: * Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer. * Have confirmed availability of tumor tissue block or slides * Have radiographic progression on or after most recent line of systemic anticancer therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Have measurable disease per RECIST v1.1 Part A: * Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy. * Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine. * Have received prior bevacizumab treatment, unless documented contraindication or intolerance. * Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance. Part B and C: * Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy * Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy Part B: \- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment. Part C: \- Have not previously received a PARPi treatment. Exclusion Criteria: Parts A, B and C: \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: * Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy. Part B and C: \- Have clinically significant proteinuria Part C: \- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

Interventions

DRUG

Sofetabart Mipitecan

DRUG

Paclitaxel

DRUG

Topotecan

DRUG

Gemcitabine

DRUG

Pegylated liposomal doxorubicin (PLD)

DRUG

MIRV

DRUG

Bevacizumab

DRUG

Carboplatin

Interested in This Trial?

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Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis

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

Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

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