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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
Sponsor: Eli Lilly and Company
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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1630
Start Date
2025-10-22
Completion Date
2031-08
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Sofetabart Mipitecan
Administered IV
Paclitaxel
Administered IV
Topotecan
Administered IV
Gemcitabine
Administered IV
Pegylated liposomal doxorubicin (PLD)
Administered IV
MIRV
Administered IV
Bevacizumab
Administered IV
Carboplatin
Administered IV
Locations (265)
University of Alabama at Birmingham
Birmingham, Alabama, United States
HonorHealth
Phoenix, Arizona, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, United States
City of Hope, Duarte
Duarte, California, United States
City of Hope Lennar
Irvine, California, United States
Kaiser Permanente Zion Medical Center
Irvine, California, United States
Moores Cancer Center
La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, United States
Stanford Women's Cancer Center
Palo Alto, California, United States
Sansum Clinic
Santa Barbara, California, United States
Kaiser Permanente
Vallejo, California, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
AdventHealth Medical Group - Porter
Denver, Colorado, United States
UConn Health
Farmington, Connecticut, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Florida Cancer Specialist- South
Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Mount Sinai Braman Comprehensive Cancer Center
Miami Beach, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialist- East
West Palm Beach, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
OSF Saint Fracis Medical Center
Peoria, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Health
Indianapolis, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Trials 365
Shreveport, Louisiana, United States
Maine Medical Center - Scarborough Campus
Scarborough, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
University of Missouri Hospital
Columbia, Missouri, United States
HCA Midwest Kansas City, MidAmerica Division, Inc.
Kansas City, Missouri, United States
Cox Medical Center North
Springfield, Missouri, United States
The Center of Hope
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Miami Valley Hospital South
Centerville, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Hilliard, Ohio, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Women & Infants Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
USO-Texas Oncology-Central/South Texas
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
US Oncology
The Woodlands, Texas, United States
USO - Texas Oncology Gulf Coast
Webster, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Ballarat Health Services
Ballarat Central, Australia
Chris O'Brien Lifehouse
Camperdown, Australia
Launceston General Hospital
Launceston, Australia
Cabrini Hospital - Malvern
Malvern, Australia
Prince of Wales Hospital
Randwick, 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