This is a clinical study that has two parts. It is testing a potential new medicinecalled Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian,peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer nolonger responds to platinum-based treatments (a type of chemotherapy). Part B looks atparticipants whose cancer still responds to platinum-based treatments. The researcherswant to find out if Sofetabart Mipitecan works better than the usual treatments thatdoctors use now and to better understand how safe it is. Each participant's time in thestudy will depend on how they respond to the treatment.
Not Provided
Drug: Sofetabart Mipitecan
Administered IV
Other Name: LY4170156
Drug: Paclitaxel
Administered IV
Drug: Topotecan
Administered IV
Drug: Gemcitabine
Administered IV
Drug: Pegylated liposomal doxorubicin (PLD)
Administered IV
Drug: MIRV
Administered IV
Drug: Bevacizumab
Administered IV
Drug: Carboplatin
Administered IV
Inclusion Criteria:
Part A and B:
- Have histologically confirmed high-grade serous or high-grade 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 greater than or equal to (≥)1 but ≤3 prior lines of
systemic cytotoxic therapy. Up to 4 lines of prior 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:
- 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 but ≤2 prior lines of systemic cytotoxic chemotherapy
- Have previously received a PARPi, per local product label, with progression on, or
within 6 months of completion of PARPi treatment.
Exclusion Criteria:
Part A and B:
- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor
payload.
Part A:
- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months
since the last dose of first-line platinum-containing chemotherapy.
Part B:
- Have clinically significant proteinuria
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, United States
HonorHealth
Phoenix 5308655, Arizona 5551752, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank 5331835, California 5332921, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles 5368361, California 5332921, United States
Stanford Women's Cancer Center
Palo Alto 5380748, California 5332921, United States
Sansum Clinic
Solvang 5397059, California 5332921, United States
Anschutz Cancer Pavilion
Aurora 5412347, Colorado 5417618, United States
UConn Health
Farmington 4834272, Connecticut 4831725, United States
Broward Health Medical Center
Fort Lauderdale 4155966, Florida 4155751, United States
Florida Cancer Specialist- South
Fort Myers 4155995, Florida 4155751, United States
Baptist MD Anderson Cancer Center
Jacksonville 4160021, Florida 4155751, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami 4164138, Florida 4155751, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751, United States
Moffitt Cancer Center
Tampa 4174757, Florida 4155751, United States
Florida Cancer Specialist- East
West Palm Beach 4177887, Florida 4155751, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah 4221552, Georgia 4197000, United States
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797, United States
Illinois Cancer Specialists
Arlington Heights 4883555, Illinois 4896861, United States
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861, United States
Rush University Medical Center
Chicago 4887398, Illinois 4896861, United States
OSF Saint Fracis Medical Center
Peoria 4905687, Illinois 4896861, United States
Franciscan Health
Indianapolis 4259418, Indiana 4921868, United States
Baptist Health Lexington
Lexington 4297983, Kentucky 6254925, United States
Norton Women's and Children's Hospital
Louisville 4299276, Kentucky 6254925, United States
Trials 365
Shreveport 4341513, Louisiana 4331987, United States
Maine Medical Center - Scarborough Campus
Scarborough 4977882, Maine 4971068, United States
Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885, United States
Sinai Hospital Of Baltimore
Baltimore 4347778, Maryland 4361885, United States
University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926, United States
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836, United States
West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836, United States
Mayo Clinic in Rochester, Minnesota
Rochester 5043473, Minnesota 5037779, United States
University of Missouri Hospital
Columbia 4381982, Missouri 4398678, United States
Cox Medical Center North
Springfield 4409896, Missouri 4398678, United States
The Center of Hope
Reno 5511077, Nevada 5509151, United States
Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760, United States
Optimum Clinical Research Group
Albuquerque 5454711, New Mexico 5481136, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success 5123853, New York 5128638, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638, United States
Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638, United States
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, United States
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348, United States
Duke Cancer Institute
Durham 4464368, North Carolina 4482348, United States
Miami Valley Hospital South
Centerville 4508204, Ohio 5165418, United States
Oncology Hematology Care Inc
Cincinnati 4508722, Ohio 5165418, United States
Cleveland Clinic
Cleveland 5150529, Ohio 5165418, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus 4509177, Ohio 5165418, United States
The Mark H Zangmeister Center
Columbus 4509177, Ohio 5165418, United States
ProMedica Flower Hospital
Sylvania 5173572, Ohio 5165418, United States
USO - Oncology Associates of Oregon, P. C.
Eugene 5725846, Oregon 5744337, United States
Providence Portland Medical Center
Portland 5746545, Oregon 5744337, United States
Kaiser Permanente Interstate Medical Office Central
Portland 5746545, Oregon 5744337, United States
Oregon Health and Science University
Portland 5746545, Oregon 5744337, United States
University of Pennsylvania Hospital
Philadelphia 4560349, Pennsylvania 6254927, United States
Asplundh Cancer Pavilion
Willow Grove 5219619, Pennsylvania 6254927, United States
Women & Infants Hospital
Providence 5224151, Rhode Island 5224323, United States
USO-Texas Oncology-Central/South Texas
Austin 4671654, Texas 4736286, United States
US Oncology
The Woodlands 4736476, Texas 4736286, United States
USO - Texas Oncology Gulf Coast
Webster 4740423, Texas 4736286, United States
Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030, United States
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135, United States
University Hospital and UW Health Clinics
Madison 5261457, Wisconsin 5279468, United States
Ballarat Health Services
Ballarat Central 8014922, Australia
Gold Coast University Hospital
Southport 2148928, Australia
Royal North Shore Hospital
St Leonards 8029783, Australia
The Townsville Hospital
Townsville 2146142, Australia
Latrobe Regional Health
Traralgon 2146108, Australia
Medizinische Universität Graz
Graz 2778067, Austria
Medizinische Universitaet Innsbruck
Innsbruck 2775220, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna 2761369, Austria
Institut Jules Bordet
Anderlecht 2803201, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges 2800931, Belgium
Antwerp University Hospital
Edegem 2799007, Belgium
AZ Maria Middelares
Ghent 2797656, Belgium
UZ Leuven
Leuven 2792482, Belgium
CPAM - Centro de Pesquisas da Amazônia
Belém 3405870, Brazil
Oncocentro de Minas Gerais
Belo Horizonte 3470127, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis 3463237, Brazil
Hospital Brasilia
Lago Sul 12432232, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro 3451190, Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro 3451190, Brazil
Clinica Amo - Rio Vermelho
Salvador 3450554, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul 3449324, Brazil
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton 5969782, Canada
Jewish General Hospital
Montreal 6077243, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke 6146143, Canada
BC Cancer Surrey
Surrey 6159905, Canada
Sunnybrook Research Institute
Toronto 6167865, Canada
Princess Margaret Cancer Centre
Toronto 6167865, Canada
Peking University First Hospital
Beijing 1816670, China
Beijing Cancer hospital
Beijing 1816670, China
The First Hospital of Jilin University
Changchun 2038180, China
The First People's Hospital of Changde City
Changde 1791121, China
Xiangya Hospital Central South University
Changsha 1815577, China
West China Second University Hospital, Sichuan University
Chengdu 1815286, China
Fujian Cancer Hospital
Fuzhou 1810821, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou 1809858, China
Zhujiang Hospital
Guangzhou 1809858, China
Sun Yat-Sen University Cancer Centre
Guangzhou 1809858, China
Zhejiang Cancer Hospital
Hangzhou 1808926, China
Shandong Cancer Hospital
Jinan 1805753, China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou 1804430, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang 1801792, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing 1799962, China
Jiangsu Province Hospital
Nanjing 1799962, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning 1799869, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai 1796236, China
Fudan University Shanghai Cancer Center
Shanghai 1796236, China
Cancer Hospital of Shantou University Medical College
Shantou 1795940, China
Peking University Shenzhen Hospital
Shenzhen 1795565, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin 1792947, China
Wuhan Union Hospital
Wuhan 1791247, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan 1791247, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an 1790630, China
Fakultní Nemocnice Brno
Brno 3078610, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jiín, Czechia
Fakultni nemocnice Olomouc
Olomouc 3069011, Czechia
Vseobecna fakultni nemocnice v Praze
Prague 3067696, Czechia
Nemocnice Tomase Bati ve Zline
Zlín 3061370, Czechia
Rigshospitalet
Copenhagen 2618425, Denmark
Institut de Cancérologie de l'Ouest
Angers 3037656, France
Centre Hospitalier de la Côte Basque
Bayonne 3034475, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux 3031582, France
CHRU de Brest
Brest 3030300, France
Centre Oscar Lambret
Lille 2998324, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges 2998286, France
Centre Leon Berard
Lyon Cedex08, France
Institut Régional du Cancer Montpellier
Montpellier 2992166, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris 2988507, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris 2988507, France
CHU Strasbourg-Hautepierre
Strasbourg 2973783, France
Universitätsklinikum Aachen
Aachen 3247449, Germany
Charité Campus Virchow-Klinikum
Berlin 2950159, Germany
Universitätsklinikum Bonn
Bonn 2946447, Germany
Universitaetsklinikum Koeln
Cologne 2886242, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden 2935022, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf 2934246, Germany
Universitaetsklinikum Erlangen
Erlangen 2929567, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen 2928810, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel 2891122, Germany
Alexandra Hospital
Athens 264371, Greece
Aretaieio Hospital
Athens 264371, Greece
General Hospital of Kalamata
Kalamata 261604, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia 10242830, Greece
Országos Onkológiai Intézet
Budapest 3054643, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen 721472, Hungary
St. Vincent's University Hospital
Dublin 2964574, Ireland
St. James's Hospital
Dublin 2964574, Ireland
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna 3181928, Italy
Ospedale Cannizzaro
Catania 2525068, Italy
Ospedale Vito Fazzi
Lecce 3174953, Italy
Azienda USL 2 Lucca
Lucca 3174530, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan 3173435, Italy
Istituto Europeo di Oncologia IRCCS
Milan 6951411, Italy
Ospedale Humanitas San Pio X
Milan 6951411, Italy
Azienda Ospedaliero Universitaria
Modena 3173331, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli 9031661, Italy
Nuovo Ospedale di Prato-S.Stefano
Prato 3169921, Italy
Ospedale Santa Maria delle Croci
Ravenna 3169561, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma 8957247, Italy
Hyogo Cancer Center
Akashi 1847966, Japan
National Cancer Center Hospital
Chūōku 10262791, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka 1863967, Japan
Saitama Medical University International Medical Center
Hidaka 6822161, Japan
National Cancer Center Hospital East
Kashiwa 1859924, Japan
The Cancer Institute Hospital of JFCR
Kōtoku 2128852, Japan
Nagoya University Hospital
Nagoya 1856057, Japan
Niigata Cancer Center Hospital
Niigata 1855431, Japan
Okayama University Hospital
Okayama 1854383, Japan
Hokkaido University Hospital
Sapporo 2128295, Japan
Tohoku University Hospital
Sendai 2111149, Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, Japan
The University of Osaka Hospital
Suita 1851483, Japan
Ehime University Hospital
Tōon 11611474, Japan
Mie University Hospital
Tsu 1849796, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City 4014338, Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City 3530597, Mexico
Higiea Oncologia
Mexico City 3530597, Mexico
INCAN
Mexico City 3530597, Mexico
Unidad Médica Onco-hematológica
Puebla City 3521081, Mexico
Hospital Angeles
Tijuana 3981609, Mexico
Erasmus Medisch Centrum
Rotterdam 2747891, Netherlands
Oslo universitetssykehus, Radiumhospitalet
Oslo 3143244, Norway
Stavanger Universitetssykehus
Stavanger 3137115, Norway
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok 776069, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow 3094802, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
Poznan 3088171, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach
Siedlce 759412, Poland
SC Memorial Healthcare International SRL
Bucharest 683506, Romania
Sc Mnt Healthcare Europe Srl
Bucharest 683506, Romania
Institutul Regional de Oncologie
Iași 675810, Romania
S C Oncocenter Oncologie Clinica S R L
Timișoara 665087, Romania
Keimyung University Dongsan Hospital
Daegu 1835329, South Korea
National Cancer Center
Goyang-si 1842485, South Korea
Seoul National University Bundang Hospital
Seongnam 6876792, South Korea
Seoul National University Hospital
Seoul 1835848, South Korea
Severance Hospital, Yonsei University Health System
Seoul 1835848, South Korea
Asan Medical Center
Seoul 1835848, South Korea
Samsung Medical Center
Seoul 1835848, South Korea
Ajou University Hospital
Suwon 1835553, South Korea
Hospital Universitari Dexeus
Barcelona 3128760, Spain
Hospital Provincial Centre de Castelló
Castellon 2519752, Spain
Hospital Universitario Virgen Nieves
Granada 2517117, Spain
Hospital Universitario HM Sanchinarro
Madrid 3117735, Spain
Hospital Universitario Virgen de la Victoria
Málaga 2514256, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes 3110040, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela 3109642, Spain
Hospital Universitario de Toledo
Toledo 2510409, Spain
Kantonsspital Baden
Baden 2661646, Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona 2661567, Switzerland
Kantonsspital Graubünden
Chur 2661169, Switzerland
Hôpitaux Universitaires de Genève (HUG)
Geneva 2660646, Switzerland
St James's University Hospital
Leeds 2644688, United Kingdom
Royal Marsden Hospital (Sutton)
London 2643743, United Kingdom
Royal Marsden Hospital (Chelsea)
London 2643743, United Kingdom
The Christie NHS Foundation Trust
Manchester 2643123, United Kingdom
Torbay Hospital
Torquay 2635650, United Kingdom
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director
Eli Lilly and Company