A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Eli Lilly and Company

Enrollment

1080

Start Date

2025-10-22

Completion Date

2028-04-01

Study Type

INTERVENTIONAL

Official Title

FRAmework-01: A Two-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.

Interventions

Sofetabart MipitecanPaclitaxelTopotecanGemcitabinePegylated liposomal doxorubicin (PLD)MIRVBevacizumabCarboplatin

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

Progression-free Survival (PFS)

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)

Secondary Outcomes

Overall Survival (OS)

Time frame: Randomization to date of death from any cause (up to 70 months)

PFS

PFS by blinded independent central review (BICR)

Time frame: 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

Time frame: Randomization to disease progression or death (up to 70 months)

Duration of Response (DOR)

DOR per RECIST v1.1

Time frame: 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

Time frame: Randomization to disease progression or death from any cause (up to 70 months)

PFS2

Time frame: 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)

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Randomization to 30 days post treatment discontinuation

Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156

Time frame: Randomization through end of treatment (up to 70 months)]

Locations

University of Alabama at Birmingham, Birmingham, United States

HonorHealth, Phoenix, United States

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center, Burbank, United States

City of Hope, Duarte, Duarte, United States

Moores Cancer Center, La Jolla, United States

UCLA Hematology/Oncology - Westwood (Building 100), Los Angeles, United States

Stanford Women's Cancer Center, Palo Alto, United States

Kaiser Permanente Zion Medical Center, San Diego, United States

Sansum Clinic, Santa Barbara, United States

Kaiser Permanente, Vallejo, United States

Anschutz Cancer Pavilion, Aurora, United States

AdventHealth Medical Group - Porter, Denver, United States

UConn Health, Farmington, United States

Broward Health Medical Center, Fort Lauderdale, United States

Florida Cancer Specialist- South, Fort Myers, United States

Baptist MD Anderson Cancer Center, Jacksonville, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, United States

Mount Sinai Comprehensive Cancer Center, Miami Beach, United States

AdventHealth Orlando, Orlando, United States

Moffitt Cancer Center, Tampa, United States

Florida Cancer Specialist- East, West Palm Beach, United States

Nancy N. & J.C. Lewis Cancer and Research Pavillion, Savannah, United States

Kapiolani Medical Center for Women and Children, Honolulu, United States

Illinois Cancer Specialists, Arlington Heights, United States

Northwestern Memorial Hospital, Chicago, United States

Rush University Medical Center, Chicago, United States

OSF Saint Fracis Medical Center, Peoria, United States

Franciscan Health, Indianapolis, United States

Baptist Health Lexington, Lexington, United States

Norton Women's and Children's Hospital, Louisville, United States

Ochsner Clinic Foundation, New Orleans, United States

Trials 365, Shreveport, United States

Maine Medical Center - Scarborough Campus, Scarborough, United States

Greater Baltimore Medical Center, Baltimore, United States

Sinai Hospital Of Baltimore, Baltimore, United States

University of Massachusetts Chan Medical School, Worcester, United States

Karmanos Cancer Institute, Detroit, United States

West Michigan Cancer Center, Kalamazoo, United States

Mayo Clinic in Rochester, Minnesota, Rochester, United States

University of Missouri Hospital, Columbia, United States

HCA Midwest Kansas City, MidAmerica Division, Inc., Kansas City, United States

Cox Medical Center North, Springfield, United States

The Center of Hope, Reno, United States

Dartmouth-Hitchcock Medical Center, Lebanon, United States

Holy Name Medical Center, Teaneck, United States

Optimum Clinical Research Group, Albuquerque, United States

Roswell Park Cancer Institute, Buffalo, United States

Northwell Health/ RJ Zuckerberg Cancer Center, Lake Success, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola, United States

Laura and Isaac Perlmutter Cancer Center, New York, United States

Icahn School of Medicine at Mount Sinai, New York, United States

Memorial Sloan Kettering Cancer Center, New York, United States

Levine Cancer Institute, Charlotte, United States

Duke Cancer Institute, Durham, United States

Miami Valley Hospital South, Centerville, United States

University of Cincinnati Medical Center, Cincinnati, United States

Oncology Hematology Care Inc, Cincinnati, United States

University Hospitals Cleveland Medical Center, Cleveland, United States

Cleveland Clinic, Cleveland, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T, Columbus, United States

The Mark H Zangmeister Center, Columbus, United States

ProMedica Flower Hospital, Sylvania, United States

USO - Oncology Associates of Oregon, P. C., Eugene, United States

Providence Portland Medical Center, Portland, United States

Kaiser Permanente Interstate Medical Office Central, Portland, United States

Oregon Health and Science University, Portland, United States

University of Pennsylvania Hospital, Philadelphia, United States

Asplundh Cancer Pavilion, Willow Grove, United States

Women & Infants Hospital, Providence, United States

Medical University of South Carolina, Charleston, United States

Vanderbilt University Medical Center, Nashville, United States

USO-Texas Oncology-Central/South Texas, Austin, United States

US Oncology, The Woodlands, United States

USO - Texas Oncology Gulf Coast, Webster, United States

Huntsman Cancer Institute, Salt Lake City, United States

Swedish Cancer Institute - Edmonds, Edmonds, United States

Swedish Medical Center, Seattle, United States

Fred Hutchinson Cancer Center, Seattle, United States

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, United States

Ballarat Health Services, Ballarat Central, Australia

Launceston General Hospital, Launceston, Australia

Cabrini Hospital - Malvern, Malvern, Australia

Goulburn Valley Health, Shepparton, Australia

Gold Coast University Hospital, Southport, Australia

Royal North Shore Hospital, St Leonards, Australia

The Townsville Hospital, Townsville, Australia

Latrobe Regional Health, Traralgon, Australia

Medizinische Universität Graz, Graz, Austria

Medizinische Universitaet Innsbruck, Innsbruck, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna, Austria

Institut Jules Bordet, Anderlecht, Belgium

AZ Sint-Jan Brugge-Oostende AV, Bruges, Belgium

Antwerp University Hospital, Edegem, Belgium

AZ Maria Middelares, Ghent, Belgium

UZ Leuven, Leuven, Belgium

CPAM - Centro de Pesquisas da Amazônia, Belém, Brazil

Oncocentro de Minas Gerais, Belo Horizonte, Brazil

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina, Florianópolis, Brazil

Hospital Brasilia, Lago Sul, Brazil

Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA, Rio de Janeiro, Brazil

Instituto D'Or Pesquisa e Ensino, Rio de Janeiro, Brazil

Clinica Amo - Rio Vermelho, Salvador, Brazil

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul, São Caetano do Sul, Brazil

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Canada

Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Canada

Jewish General Hospital, Montreal, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T, Sherbrooke, Canada

BC Cancer Surrey, Surrey, Canada

Sunnybrook Research Institute, Toronto, Canada

Princess Margaret Cancer Centre, Toronto, Canada

Peking University First Hospital, Beijing, China

Beijing Cancer hospital, Beijing, China

The First Hospital of Jilin University, Changchun, China

The First People's Hospital of Changde City, Changde, China

Xiangya Hospital Central South University, Changsha, China

West China Second University Hospital, Sichuan University, Chengdu, China

Sichuan Provincial People's Hospital, Chengdu, China

Fujian Cancer Hospital, Fuzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

Zhujiang Hospital, Guangzhou, China

Sun Yat-Sen University Cancer Centre, Guangzhou, China

Zhejiang Cancer Hospital, Hangzhou, China

Shandong Cancer Hospital, Jinan, China

Gansu Provincial Maternity and Child Care Hospital, Lanzhou, China

The First Affiliated Hospital of Henan University of Science &Technology, Luoyang, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, China

Jiangsu Province Hospital, Nanjing, China

Guangxi Medical University Affiliated Tumor Hospital, Nanning, China

Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China

Fudan University Shanghai Cancer Center, Shanghai, China

Cancer Hospital of Shantou University Medical College, Shantou, China

Peking University Shenzhen Hospital, Shenzhen, China

Tianjin Medical University Cancer Institute & Hospital, Tianjin, China

Wuhan Union Hospital, Wuhan, China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China

Fakultní Nemocnice Brno, Brno, Czechia

Nemocnice AGEL Novy Jicin a.s., Nový Jiín, Czechia

Fakultni nemocnice Olomouc, Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze, Prague, Czechia

Nemocnice Tomase Bati ve Zline, Zlín, Czechia

Rigshospitalet, Copenhagen, Denmark

Vejle Sygehus, Vejle, Denmark

Institut de Cancérologie de l'Ouest, Angers, France

Centre Hospitalier de la Côte Basque, Bayonne, France

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, France

CHRU de Brest, Brest, France

Centre Oscar Lambret, Lille, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren, Limoges, France

Centre Leon Berard, Lyon Cedex08, France

Institut Régional du Cancer Montpellier, Montpellier, France

Hopitaux Universitaires Paris Centre-Hopital Cochin, Paris, France

Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, France

CHU Strasbourg-Hautepierre, Strasbourg, France

Universitätsklinikum Aachen, Aachen, Germany

Charité Campus Virchow-Klinikum, Berlin, Germany

Universitätsklinikum Bonn, Bonn, Germany

Universitaetsklinikum Koeln, Cologne, Germany

Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Germany

Universitaetsklinikum Duesseldorf, Düsseldorf, Germany

Universitaetsklinikum Erlangen, Erlangen, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany

Alexandra Hospital, Athens, Greece

Aretaieio Hospital, Athens, Greece

General Hospital of Kalamata, Kalamata, Greece

General Oncology Hospital of Kifissia "Agioi Anargiroi", Nea Kifissia, Greece

Országos Onkológiai Intézet, Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Cork University Hospital, Cork, Ireland

St. Vincent's University Hospital, Dublin, Ireland

St. James's Hospital, Dublin, Ireland

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna, Italy

Ospedale Cannizzaro, Catania, Italy

Ospedale Vito Fazzi, Lecce, Italy

Azienda USL 2 Lucca, Lucca, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Istituto Europeo di Oncologia IRCCS, Milan, Italy

Ospedale Humanitas San Pio X, Milan, Italy

Azienda Ospedaliero Universitaria, Modena, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy

Nuovo Ospedale di Prato-S.Stefano, Prato, Italy

Ospedale Santa Maria delle Croci, Ravenna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, Italy

Hyogo Cancer Center, Akashi, Japan

National Cancer Center Hospital, Chūōku, Japan

National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

Saitama Medical University International Medical Center, Hidaka, Japan

Kagoshima University Hospital, Kagoshima, Japan

National Cancer Center Hospital East, Kashiwa, Japan

The Cancer Institute Hospital of JFCR, Kōtoku, Japan

Nagoya University Hospital, Nagoya, Japan

Niigata Cancer Center Hospital, Niigata, Japan

Okayama University Hospital, Okayama, Japan

Gunma Prefectural Cancer Center, Otashi, Japan

Hokkaido University Hospital, Sapporo, Japan

Tohoku University Hospital, Sendai, Japan

Iwate Medical University Hospital, Shiwa-gun Yahaba-cho, Japan

The University of Osaka Hospital, Suita, Japan

Ehime University Hospital, Tōon, Japan

Mie University Hospital, Tsu, Japan

Scientia Investigacion Clinica S.C., Chihuahua City, Mexico

Health Pharma Professional Research S.A. de C.V:, Mexico City, Mexico

Higiea Oncologia, Mexico City, Mexico

INCAN, Mexico City, Mexico

Unidad Médica Onco-hematológica, Puebla City, Mexico

Hospital Angeles, Tijuana, Mexico

University Medical Center Groningen, Groningen, Netherlands

Erasmus Medisch Centrum, Rotterdam, Netherlands

Oslo universitetssykehus, Radiumhospitalet, Oslo, Norway

Stavanger Universitetssykehus, Stavanger, Norway

Uniwersytecki Szpital Kliniczny w Białymstoku, Bialystok, Poland

Uniwersyteckie Centrum Kliniczne, Gdansk, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow, Poland

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie, Poznan, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach, Siedlce, Poland

SC Memorial Healthcare International SRL, Bucharest, Romania

Sc Mnt Healthcare Europe Srl, Bucharest, Romania

Institutul Regional de Oncologie, Iași, Romania

S C Oncocenter Oncologie Clinica S R L, Timișoara, Romania

Keimyung University Dongsan Hospital, Daegu, South Korea

National Cancer Center, Goyang-si, South Korea

Seoul National University Bundang Hospital, Seongnam, South Korea

Seoul 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

Ajou University Hospital, Suwon, South Korea

Hospital Universitari Dexeus, Barcelona, Spain

Hospital Provincial Centre de Castelló, Castellon, Spain

Hospital Universitario Virgen Nieves, Granada, Spain

Hospital Universitario HM Sanchinarro, Madrid, Spain

Hospital Universitario Virgen de la Victoria, Málaga, Spain

Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain

CHUS - Hospital Clinico Universitario, Santiago de Compostela, Spain

Hospital Universitario de Toledo, Toledo, Spain

Kantonsspital Baden, Baden, Switzerland

Ospedale Regionale Bellinzona e Valli, Bellinzona, Switzerland

Kantonsspital Graubünden, Chur, Switzerland

Hôpitaux Universitaires de Genève (HUG), Geneva, Switzerland

Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung Niao Sung Dist, Taiwan

China Medical University Hospital, Taichung, Taiwan

Taichung Veterans General Hospital, Taichung, Taiwan

National Cheng Kung University Hospital, Tainan, Taiwan

National Taiwan University Hospital, Taipei, Taiwan

Mackay Memorial Hospital, Taipei, Taiwan

Taipei Veterans General Hospital, Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District, Taiwan

Royal United Hospitals NHS Foundation Trust, Bath, United Kingdom

St James's University Hospital, Leeds, United Kingdom

Royal Marsden Hospital (Sutton), London, United Kingdom

Royal Marsden Hospital (Chelsea), London, United Kingdom

The Christie NHS Foundation Trust, Manchester, United Kingdom

Torbay Hospital, Torquay, United Kingdom