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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

RecruitingPhase 3

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.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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).

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 1,630 · Started: Oct 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07213804

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham (Not yet recruiting)
ArizonaHonorHealth, Phoenix
CaliforniaRoy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center, Burbank
City of Hope, Duarte, Duarte (Not yet recruiting)
City of Hope Lennar, Irvine (Not yet recruiting)
Kaiser Permanente Zion Medical Center, Irvine
Moores Cancer Center, La Jolla (Not yet recruiting)
UCLA Hematology/Oncology - Westwood (Building 100), Los Angeles
Stanford Women's Cancer Center, Palo Alto
Sansum Clinic, Santa Barbara
Kaiser Permanente, Vallejo (Not yet recruiting)
ColoradoAnschutz Cancer Pavilion, Aurora
AdventHealth Medical Group - Porter, Denver (Not yet recruiting)
ConnecticutUConn Health, Farmington
FloridaBroward Health Medical Center, Fort Lauderdale
Florida Cancer Specialist- South, Fort Myers
Baptist MD Anderson Cancer Center, Jacksonville
University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami
Mount Sinai Braman Comprehensive Cancer Center, Miami Beach
AdventHealth Orlando, Orlando (Not yet recruiting)
Moffitt Cancer Center, Tampa (Not yet recruiting)
Florida Cancer Specialist- East, West Palm Beach
GeorgiaWinship Cancer Institute, Emory University, Atlanta
Nancy N. & J.C. Lewis Cancer and Research Pavillion, Savannah (Not yet recruiting)
HawaiiKapiolani Medical Center for Women and Children, Honolulu (Not yet recruiting)
IllinoisIllinois Cancer Specialists, Arlington Heights
Northwestern Memorial Hospital, Chicago
Rush University Medical Center, Chicago (Not yet recruiting)
The University of Chicago Medicine, Chicago (Not yet recruiting)
OSF Saint Fracis Medical Center, Peoria
IndianaFranciscan Health, Indianapolis
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis (Not yet recruiting)
KentuckyBaptist Health Lexington, Lexington
Norton Women's and Children's Hospital, Louisville
LouisianaOchsner Clinic Foundation, New Orleans (Not yet recruiting)
Trials 365, Shreveport
MaineMaine Medical Center - Scarborough Campus, Scarborough
MarylandGreater Baltimore Medical Center, Baltimore
Sinai Hospital Of Baltimore, Baltimore
MassachusettsUniversity of Massachusetts Chan Medical School, Worcester (Not yet recruiting)
MichiganKarmanos Cancer Institute, Detroit
West Michigan Cancer Center, Kalamazoo
MinnesotaMayo Clinic in Rochester, Minnesota, Rochester (Not yet recruiting)
MissouriUniversity of Missouri Hospital, Columbia
HCA Midwest Kansas City, MidAmerica Division, Inc., Kansas City (Not yet recruiting)
Cox Medical Center North, Springfield
NevadaThe Center of Hope, Reno
New HampshireDartmouth-Hitchcock Medical Center, Lebanon
New MexicoOptimum Clinical Research Group, Albuquerque (Not yet recruiting)
New YorkRoswell Park Cancer Institute, Buffalo (Not yet recruiting)
Northwell Health/ RJ Zuckerberg Cancer Center, Lake Success
Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola
Icahn School of Medicine at Mount Sinai, New York (Not yet recruiting)
Laura and Isaac Perlmutter Cancer Center, New York
Memorial Sloan Kettering Cancer Center, New York
North CarolinaDuke Cancer Institute, Durham
OhioMiami Valley Hospital South, Centerville
Oncology Hematology Care Inc, Cincinnati
University of Cincinnati Medical Center, Cincinnati (Not yet recruiting)
Cleveland Clinic, Cleveland
Fairview Hospital, Cleveland (Not yet recruiting)
University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
The Mark H Zangmeister Center, Columbus
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T, Hilliard
Cleveland Clinic - Hillcrest Hospital, Mayfield Heights
ProMedica Flower Hospital, Sylvania (Not yet recruiting)
OklahomaUniversity of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City (Not yet recruiting)
OregonUSO - Oncology Associates of Oregon, P. C., Eugene
Kaiser Permanente Interstate Medical Office Central, Portland
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
PennsylvaniaJefferson Health Honickman Center, Philadelphia
University of Pennsylvania Hospital, Philadelphia
Asplundh Cancer Pavilion, Willow Grove
Rhode IslandWomen & Infants Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston (Not yet recruiting)
TennesseeVanderbilt University Medical Center, Nashville
TexasUSO-Texas Oncology-Central/South Texas, Austin
UT Southwestern Medical Center, Dallas (Not yet recruiting)
US Oncology, The Woodlands
USO - Texas Oncology Gulf Coast, Webster
UtahHuntsman Cancer Institute, Salt Lake City
WashingtonSwedish Cancer Institute - Edmonds, Edmonds
Fred Hutchinson Cancer Center, Seattle
Swedish Medical Center, Seattle
WisconsinUniversity of Wisconsin Carbone Cancer Center - University Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.