Ovarian NeoplasmsPhase 3FRAmework-01NCT07213804
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
A Phase 3 study testing Sofetabart Mipitecan, Paclitaxel and Topotecan in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by Eli Lilly and Company at 265 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- What is being tested?
- Sofetabart Mipitecan, Paclitaxel and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,630 participants
- Where
- 265 sitesin 27 countries
- Study dates
- 22 Oct 2025to Aug 2031
- Phase
- Phase 3
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
- 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
Show all 18Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
265 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
265 sites in 27 countries
United States86 sites, 86 recruiting
- Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
847-259-4482
Urszula Sobol
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Beryl Manning-Geist
- Recruiting
Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Lindsay Brubaker
- Recruiting
USO-Texas Oncology-Central/South Texas
Austin, Texas, 78731
Lynne Knowles
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Fong Liu
- Recruiting
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215
410-601-9083
Pallavi Kumar
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
205-934-4986
Rebecca Arend
- Not yet recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Emese Zsiros
- Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, 91505
818-748-4726
Diana Pearre
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
937-438-7819
Michael Guy
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Brian Orr
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Emma Barber
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Alexander Cohen
- Not yet recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637
Katherine Kurnit
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Thomas Herzog
- Recruiting
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
513-751-2273 x22401
Ajit Gubbi
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
216-844-3954
Sarah Lynam
- Recruiting
Fairview Hospital
Cleveland, Ohio, 44111
216-444-6601
Kevin Elias
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
216-444-6601
Kevin Elias
- Recruiting
University of Missouri Hospital
Columbia, Missouri, 65212
573-882-7440
Mark Hunter
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Emily Whitman
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
214-64803026
Jayanthi Lea
- Not yet recruiting
AdventHealth Medical Group - Porter
Denver, Colorado, 80210
Neil Phippen
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Robert Morris
- Recruiting
City of Hope, Duarte
Duarte, California, 91010
Mihae Song
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
919-684-3765
Angeles Secord
- Recruiting
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Kristin Taylor
- Recruiting
USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon, 97401
Charles Anderson
- Recruiting
UConn Health
Farmington, Connecticut, 06030-8010
860-679-2100
Jennifer Jorgensen
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Scott Jordan
- Recruiting
Florida Cancer Specialist- South
Fort Myers, Florida, 33901
Elizabeth Guancial
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Hilliard, Ohio, 43026
Robert Neff
- Not yet recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Michael Carney
- Not yet recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Jessica Parker Metter
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
Nibal Saad
- Recruiting
City of Hope Lennar
Irvine, California, 92618
626-218-8070
Mihae Song
- Recruiting
Kaiser Permanente Zion Medical Center
Irvine, California, 92618
714-393-6482
Devansu Tewari
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
904-202-7300
Lauren Hand
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
269-382-2500
Anna Hoekstra
- Not yet recruiting
HCA Midwest Kansas City, MidAmerica Division, Inc.
Kansas City, Missouri, 64132
314-374-8491
Alaa Elbendary
- Not yet recruiting
Moores Cancer Center
La Jolla, California, 92093
Ramez Eskander
- Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Veena John
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Michael Pearl
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
859-278-5671
Hope Cottrill
- Not yet recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
859-323-3975
Rachel Miller
- Recruiting
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, 90095
310-794-3639
Ritu Salani
- Recruiting
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
Monica Vetter
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Janelle Sobecki
- Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
216-444-6601
Kevin Elias
- Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Abdulrahman Sinno
- Recruiting
Mount Sinai Braman Comprehensive Cancer Center
Miami Beach, Florida, 33140
305-535-3358
Brian Slomovitz
- Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
212-731-6455
Bhavana Pothuri
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Alaina Brown
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
504-842-3910
Katrina Wade
- Recruiting
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
212-731-6455
Bhavana Pothuri
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
212-604-6059
Stephanie Blank
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
646-888-4227
Roisin OCearbhaill
- Not yet recruiting
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Jacqueline Bohn
- Not yet recruiting
AdventHealth Orlando
Orlando, Florida, 32803
407-622-8774
Robert Holloway
- Recruiting
Stanford Women's Cancer Center
Palo Alto, California, 94305
Kristin Bixel
- Recruiting
OSF Saint Fracis Medical Center
Peoria, Illinois, 61637
Michelle Rowland
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Lainie Martin
- Recruiting
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
215-481-6069
Mitchell Edelson
- Recruiting
HonorHealth
Phoenix, Arizona, 85016
Lyndsay Willmott
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Christopher Darus
- Recruiting
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
503-249-3315
Sandeep Mashru
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
503-494-7999
Elizabeth Munro
- Recruiting
Women & Infants Hospital
Providence, Rhode Island, 02905
Elizabeth Lokich
- Recruiting
The Center of Hope
Reno, Nevada, 89511
775-327-4673
Peter Lim
- Not yet recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Saravut Weroha
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
801-213-5750
Theresa Werner
- Recruiting
Sansum Clinic
Santa Barbara, California, 93105
Eric Bank
- Recruiting
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, 31405
Sarah Gill
- Recruiting
Maine Medical Center - Scarborough Campus
Scarborough, Maine, 04074
Leslie Bradford
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Kristin Taylor
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
John Liao
- Recruiting
Trials 365
Shreveport, Louisiana, 71103
Destin Black
- Recruiting
Cox Medical Center North
Springfield, Missouri, 65802
417-875-3065
Ashley Valenzuela
- Not yet recruiting
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Anjalika Gandhi
- Not yet recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Hye Sook Chon
- Recruiting
US Oncology
The Woodlands, Texas, 77380
SMO Sarah Cannon Research Inst.
- Not yet recruiting
Kaiser Permanente
Vallejo, California, 94589
925-295-4030
Juraj Kavecansky
- Recruiting
USO - Texas Oncology Gulf Coast
Webster, Texas, 77598-4420
281-332-7505
Terri Pustilnik
- Recruiting
Florida Cancer Specialist- East
West Palm Beach, Florida, 33401
Shaachi Gupta
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
215-481-6069
Mitchell Edelson
- Not yet recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
508-334-1160
Susan Zweizig
China23 sites, 23 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100032
Jun Hu
- Recruiting
Beijing Cancer hospital
Beijing, 100142
Yunong Gao
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
Songling Zhang
- Recruiting
The First People's Hospital of Changde City
Changde, 415003
Tao Wu
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
Yu Zhang
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
honglin hu
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
Qunxian Rao
- Recruiting
Zhujiang Hospital
Guangzhou, 510280
Xuefeng Wang
- Recruiting
Sun Yat-Sen University Cancer Centre
Guangzhou, 511400
Jundong Li
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
Jianqing Zhu
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
Liang Chen
- Recruiting
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, 730050
Chongli Guan
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471023
15225067070
Dongmei Fan
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000
Huaijun Zhou
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
Wenjun Cheng
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021
He Wang
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200011; 200090
Yisheng Wang
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
8613601772486
Xiaohua Wu
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, 515031
Li Zhou
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, 518036
Changzhong Li
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
Ke Wang
- Recruiting
Wuhan Union Hospital
Wuhan, 430022
Guiling Li
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
18627906399
Changyu Wang
Japan17 sites, 17 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, 673-8558
81120023812
Koji Matsumoto
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
81120023812
Kan Yonemori
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
81120023812
Kazuya Ariyoshi
- Recruiting
Saitama Medical University International Medical Center
Hidaka, 350-1298
81120023812
Kosei Hasegawa
- Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
81120023812
Shinichi Togami
- Not yet recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
81120023812
Kenichi Harano
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
81120023812
Mayu Yunokawa
- Recruiting
Nagoya University Hospital
Nagoya, 466-8560
81120023812
Hiroaki Kajiyama
- Recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566
81120023812
Akira Kikuchi
- Recruiting
Okayama University Hospital
Okayama, 700-8558
81120023812
Shoji Nagao
- Recruiting
Gunma Prefectural Cancer Center
Otashi, 373-8550
81120023812
Soichi Yamashita
- Recruiting
Hokkaido University Hospital
Sapporo, 060-8648
81120023812
Hidemichi Watari
- Recruiting
Tohoku University Hospital
Sendai, 980-8574
81120023812
Muneaki Shimada
- Recruiting
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, 028-3695
81120023812
Tsukasa Baba
- Recruiting
The University of Osaka Hospital
Suita, 565-0871
81120023812
Kodama Michiko
- Recruiting
Ehime University Hospital
Tōon, 791-0295
81120023812
Tomoka Usami
- Recruiting
Mie University Hospital
Tsu, 514-8507
81120023812
Eiji Kondo
France12 sites, 12 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Paule Augereau
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64109
33559443762
Thomas Grellety
- Not yet recruiting
CHU Besançon
Besançon, 25000
33370632403
Laura Mansi
- Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Coriolan Lebreton
- Recruiting
CHRU de Brest
Brest, 29609
Laura Deiana
- Recruiting
Centre Oscar Lambret
Lille, 59020
Hortense Chevalier
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
0555056396
Elise Deluche
- Recruiting
Centre Leon Berard
Lyon Cedex08, 69373
Isabelle-Laure Ray-Coquard
- Recruiting
Institut Régional du Cancer Montpellier
Montpellier, 34298
334 67 61 24 19
Stanislas QUESADA
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
Jerome Alexandre
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
33144741013
Antoine Angelergues
- Recruiting
CHU Strasbourg-Hautepierre
Strasbourg, 67098
Lauriane EBERST
Italy12 sites, 12 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Claudio Zamagni
- Recruiting
Ospedale Cannizzaro
Catania, 95126
390957262708
Giuseppa Scandurra
- Not yet recruiting
Ospedale Vito Fazzi
Lecce, 73100
0039 0832661807
Ugo De Giorgi
- Recruiting
Azienda USL 2 Lucca
Lucca, 55100
39 0583 449545
Editta Baldini
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Monika Ducceschi
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
390257489543
Nicoletta Colombo
- Recruiting
Ospedale Humanitas San Pio X
Milan, 20159
Domenica Lorusso
- Not yet recruiting
Azienda Ospedaliero Universitaria
Modena, 41125
Cinzia Baldessari
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Sabrina Cecere
- Recruiting
Nuovo Ospedale di Prato-S.Stefano
Prato, 59100
0574802520
Elena Zafarana
- Not yet recruiting
Ospedale Santa Maria delle Croci
Ravenna, 48121
CLAUDIA CASANOVA
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Anna Fagotti
Australia10 sites, 10 recruiting
- Recruiting
Ballarat Health Services
Ballarat Central, 3350
0353206500
LeeNa Teo
- Recruiting
Chris O'Brien Lifehouse
Camperdown, 2050
+61 2 8514 0149
Michelle Harrison
- Recruiting
Launceston General Hospital
Launceston, 7250
+61 3 6777 6777
Jeremy Power
- Recruiting
Cabrini Hospital - Malvern
Malvern, 3144
1300300977
Gary Richardson
- Recruiting
Prince of Wales Hospital
Randwick, 2031
Yeh Chen Lee
- Recruiting
Goulburn Valley Health
Shepparton, 3630
+61 3 5832 2322
Arvind Sahu
- Not yet recruiting
Gold Coast University Hospital
Southport, 4215
(07) 5687 0633
Sean Hill
- Recruiting
Royal North Shore Hospital
St Leonards, 2065
Connie Diakos
- Recruiting
The Townsville Hospital
Townsville, 4814
61744331111
Joanne Tan
- Recruiting
Latrobe Regional Health
Traralgon, 3844
Bhavini Shah
Germany10 sites, 10 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
00492418088400
Elmar Stickeler
- Recruiting
Charité Campus Virchow-Klinikum
Berlin, 13353
+4930450664469
Elena Braicu
- Not yet recruiting
Universitätsklinikum Bonn
Bonn, 53127
00492418088400
Elmar Stickeler
- Not yet recruiting
Universitaetsklinikum Koeln
Cologne, 50931
00492418088400
Elmar Stickeler
- Not yet recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
00493514586728
Pauline Wimberger
- Not yet recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
00492418088400
Elmar Stickeler
- Not yet recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
+4991318533572
Peter Fasching
- Not yet recruiting
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136
Sabrina Kaiser
- Not yet recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
+4943150021686
Marion van Mackelenbergh
- Not yet recruiting
Universitaetsklinikum Ulm
Ulm, 89075
Sabine Heublein
Brazil8 sites, 8 recruiting
- Recruiting
CPAM - Centro de Pesquisas da Amazônia
Belém, 66073-005
5591999809897
Bruno Fernandes
- Recruiting
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060
Angelica Rodrigues
- Recruiting
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, 88020-210
4833804828
Maria Eduarda Meyer
- Recruiting
Hospital Brasilia
Lago Sul, 71635580
Romualdo Barroso-Sousa
- Not yet recruiting
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Alexssandra Dos Santos
- Not yet recruiting
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22271-110
Eduardo Paulino
- Recruiting
Clinica Amo - Rio Vermelho
Salvador, 41950-640
557130218735
Aknar Calabrich
- Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, 09541-270
551149935491
Patricia Santi
South Korea8 sites, 8 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
So Jin Shin
- Recruiting
National Cancer Center
Goyang-si, 10408
Myong Cheol Lim
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Kidong Kim
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae-Weon Kim
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Jung-Yun Lee
- Recruiting
Asan Medical Center
Seoul, 05505
Dae Yeon Kim
- Recruiting
Samsung Medical Center
Seoul, 06351
Chel Hun Choi
- Recruiting
Ajou University Hospital
Suwon, 16499
+82-31-219-5251
Suk Joon Chang
Spain8 sites, 8 recruiting
- Recruiting
Hospital Universitari Dexeus
Barcelona, 08028
34935460139
Alejandro Martínez Bueno
- Recruiting
Hospital Provincial Centre de Castelló
Castellon, 12002
Nuria Ruiz Miravet
- Recruiting
Hospital Universitario Virgen Nieves
Granada, 18012
+34 675304319
Fernando Galvez Montosa
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
917567800
Arantzazu Barquin Garcia
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Marcos Iglesias Campos
- Recruiting
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702
636443385
María Merino
- Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706
Juan Cueva Bañuelos
- Recruiting
Hospital Universitario de Toledo
Toledo, 45007
María del Carmen Esteban Esteban
Taiwan8 sites, 8 recruiting
- Not yet recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301
Hung-Chun Fu
- Recruiting
China Medical University Hospital
Taichung, 404332
886-422052121 ext 2063
Lian-Shung Yeh
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407
Chien-Hsing Lu
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 704
Yu-Fang Huang
- Recruiting
National Taiwan University Hospital
Taipei, 10002
0223123456
Lin-Hung Wei
- Not yet recruiting
Mackay Memorial Hospital
Taipei, 10449
Chih-Long Chang
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Peng-Hui Wang
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
WEI CHUN CHEN
Canada7 sites, 7 recruiting
- Not yet recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2
4025213721
Prafull Ghatage
- Not yet recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, L8V5C2
Nidhi Kumar Tyagi
- Not yet recruiting
Jewish General Hospital
Montreal, H3T 1E2
Susie Lau
- Not yet recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke, J1H 5N4
8193461110 x 12890
Paul Bessette
- Not yet recruiting
BC Cancer Surrey
Surrey, V3V 1Z2
604-587-4314
Aalok Kumar
- Not yet recruiting
Sunnybrook Research Institute
Toronto, M4N 3M5
4164805000x4026
Lilian Gien
- Recruiting
Princess Margaret Cancer Centre
Toronto, M5G 2M9
Amit Oza
Mexico6 sites, 6 recruiting
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
6146883416
Enrique Zamudio Lozoya
- Not yet recruiting
Health Pharma Professional Research S.A. de C.V:
Mexico City, 03100
Denisse Añorve Bailon
- Not yet recruiting
Higiea Oncologia
Mexico City, 11819
525552731712
Manuel Magallanes Maciel
- Not yet recruiting
INCAN
Mexico City, 14080
Claudia Cano Blanco
- Recruiting
Unidad Médica Onco-hematológica
Puebla City, 72424
52 2229478020
Eduardo Tellez Bernal
- Recruiting
Hospital Angeles
Tijuana, 22010
6646351845
Jennifer Vanessa Ramirez Puente
United Kingdom6 sites, 6 recruiting
- Recruiting
Royal United Hospitals NHS Foundation Trust
Bath, BA1 3NG
Rebecca Bowen
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
0113 2068336
David Jackson
- Recruiting
Royal Marsden Hospital (Sutton)
London, SM2 5PT
442086613979
Susana Banerjee
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
442086613979
Susana Banerjee
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
+44 161 446 3391
Andrew Clamp
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
01803655393
Nangi Lo
Belgium5 sites, 5 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
3225413279
Laura Polastro
- Recruiting
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000
3250452806
Eveline De Cuypere
- Not yet recruiting
Antwerp University Hospital
Edegem, 2650
+32 3 821 41 60
Laure-Anne Teuwen
- Recruiting
AZ Maria Middelares
Ghent, 9000
3292469500
Christof Vulsteke
- Recruiting
UZ Leuven
Leuven, 3000
016344634
Els Van Nieuwenhuysen
Czechia5 sites, 5 recruiting
- Recruiting
Fakultní Nemocnice Brno
Brno, 602 00
+420 532 238 276
Marketa Bednarikova
- Recruiting
Nemocnice AGEL Novy Jicin a.s.
Nový Jiín, 741 01
Vojtech Tlusty
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
420588444295
Bohuslav Melichar
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
+420224967451
David Cibula
- Recruiting
Nemocnice Tomase Bati ve Zline
Zlín, 762 75
+420577552344
Marketa Pospiskova
Poland5 sites, 5 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
Pawel Knapp
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Dagmara Klasa-Mazurkiewicz
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501
0048123516700
Piotr Wysocki
- Recruiting
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
Poznan, 61-866
Bartosz Urbanski
- Recruiting
Mazowiecki Szpital Wojewódzki w Siedlcach
Siedlce, 08-110
Lubomir Bodnar
Greece4 sites, 4 recruiting
- Recruiting
Alexandra Hospital
Athens, 115 28
302132162845
Michalis Liontos
- Recruiting
Aretaieio Hospital
Athens, 115 28
306946462998
FLORA ZAGOURI
- Recruiting
General Hospital of Kalamata
Kalamata, 241 00
SOFIA STAMATOPOULOU
- Recruiting
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, 145 64
00306973386584
Roubini Zakopoulou
Romania4 sites, 4 recruiting
- Recruiting
SC Memorial Healthcare International SRL
Bucharest, 013812
40721298677
Ingrid Iordan
- Recruiting
Sc Mnt Healthcare Europe Srl
Bucharest, 013975
Bogdan Georgescu
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
0753671616
GEORGIANA FLORENTA
- Recruiting
S C Oncocenter Oncologie Clinica S R L
Timișoara, 300166
0040745146020
Roxana Scheusan
Switzerland4 sites, 4 recruiting
- Not yet recruiting
Kantonsspital Baden
Baden, 5404
0792739807
Martin Heubner
- Not yet recruiting
Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Esteban Ciliberti
- Not yet recruiting
Kantonsspital Graubünden
Chur, 7000
Ursula Hasler-Strub
- Not yet recruiting
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211
intidhar labidi-galy
Austria3 sites, 3 recruiting
- Not yet recruiting
Medizinische Universität Graz
Graz, 8036
Vassiliki Kolovetsiou Kreiner
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Irina Tsibulak
- Not yet recruiting
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
004314040061030
Stephan Polterauer
Hungary3 sites, 3 recruiting
- Recruiting
Országos Onkológiai Intézet
Budapest, 1122
36309313155
Andrea Bagameri
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Robert Poka
- Not yet recruiting
Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
Kofi Agyemang-Prempeh
Singapore3 sites, 3 recruiting
- Not yet recruiting
National University Hospital
Singapore, 119074
David Tan
- Not yet recruiting
National Cancer Centre Singapore
Singapore, 168583
+65 64368000
Wen Yee Chay
- Not yet recruiting
Curie Oncology - Farrer
Singapore, 217562
John Chia
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Trine Noettrup
- Recruiting
Vejle Sygehus
Vejle, 7100
+45 79406815
Caroline Thomsen
Ireland2 sites, 2 recruiting
- Not yet recruiting
St. Vincent's University Hospital
Dublin, D04 T6F4
Lynda McSorley
- Not yet recruiting
St. James's Hospital
Dublin, D08 E9P6
Karen Cadoo
Netherlands2 sites, 2 recruiting
- Not yet recruiting
University Medical Center Groningen
Groningen, 9713 GZ
+31 6 55256014
A.K.L. Reyners
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
0107034897
Ingrid Boere
Norway2 sites, 2 recruiting
- Recruiting
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379
Kristina Lindemann
- Recruiting
Stavanger Universitetssykehus
Stavanger, 4011
Elisabeth Nilsen
About this study
Official title: FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
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.
- Being tested
- Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin (PLD)
- Keywords
- Folate Receptor Alpha, Antibody-drug Conjugate, Platinum-Resistant, Platinum-Sensitive
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofetabart MipitecanDrug
Also called LY4170156, Sofe-M
Administered IV
PaclitaxelDrug
Administered IV
TopotecanDrug
Administered IV
GemcitabineDrug
Administered IV
Pegylated liposomal doxorubicin (PLD)Drug
Administered IV
MIRVDrug
Administered IV
BevacizumabDrug
Administered IV
CarboplatinDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: Sofetabart Mipitecan | Experimental | Administered intravenously (IV). Receives: Drug: Sofetabart Mipitecan |
| Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV) | Active comparator | Investigator's Choice of Chemotherapy or MIRV given IV. Receives: Drug: Paclitaxel; Drug: Topotecan; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: MIRV |
| Part B: Sofetabart Mipitecan plus Bevacizumab | Experimental | Administered IV. Receives: Drug: Sofetabart Mipitecan; Drug: Bevacizumab |
| Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab | Active comparator | Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. Receives: Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Bevacizumab; Drug: Carboplatin |
| Part C: Sofetabart Mipitecan plus Bevacizumab | Experimental | Administered IV Receives: Drug: Sofetabart Mipitecan; Drug: Bevacizumab |
| Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab | Active comparator | Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. Receives: Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Bevacizumab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured: Randomization to radiographic progression or death from any cause (up to 70 months)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)
Measured: Randomization to radiographic progression or death from any cause (up to 70 months)
Secondary outcomes (13)
Overall Survival (OS)
Measured: Randomization to date of death from any cause (up to 70 months)
PFS
PFS by blinded independent central review (BICR)
Measured: Randomization to radiographic progression or death from any cause (up to 70 months)
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
ORR per RECIST v1.1
Measured: Randomization to disease progression or death (up to 70 months)
Duration of Response (DOR)
DOR per RECIST v1.1
Measured: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
DCR per RECIST v1.1
Measured: Randomization to disease progression or death from any cause (up to 70 months)
PFS2
Measured: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)
Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD)
Measured: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)
Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG)
Per GCIG
Measured: Randomization to 30 days post treatment discontinuation
Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5)
FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. High side effect bother is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.
Measured: Randomization to 30 days post treatment discontinuation
Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28)
The EORTC OV28 consists of 28 items covering 3 functional scales and 5 symptom scales. The Abdominal/GI symptom scale ranges from 0 to 100. Higher scores indicate worse symptoms.
Measured: Randomization to 30 days post treatment discontinuation
Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale
The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 0 - 100. Higher score represents better overall HRQoL.
Measured: Randomization to 30 days post treatment discontinuation
Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156
Measured: Randomization through end of treatment (up to 70 months)]
PFS
PFS by investigator assessment per RECIST v1.1
Measured: Randomization to radiographic progression or death from any cause (up to 70 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start22 Oct 2025
- Primary completionNov 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213804
- Sponsor's protocol ID
- 27727
- Other IDs
- 2025-522255-25-00, J5E-MC-JZXB, GOG-3133, ENGOT-ov97/GINECO-NOGGO-AGO-A, APGOT-OV17, 2025
- Acronym
- FRAmework-01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Ray-Coquard I, O'Malley DM, Oaknin A, Madariaga A, Lakhani N, McKean W, Perez-Fidalgo A, Okera M, Kitano S, Koyama T, Frenel JS, Curigliano G, Khajawa MR, Cheol Lim M, Lorusso D, Pilla Reddy V, Speck RM, Gilligan AM, Szpurka AM, Manvelyan M, Wu Y, Wang C, Avsar E, Friedman CF, Sachdeva D, Kyi C, Pothuri B. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study. Ann Oncol. 2026 Oct 8:S0923-7534(26)06781-5. doi: 10.1016/j.annonc.2026.10.001. Online ahead of print.
PubMed 42849725