ClinicalTrials.gov record
Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07213804

Public ClinicalTrials.gov record NCT07213804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 11:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Study identification

NCT ID
NCT07213804
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
1,080 participants

Conditions and interventions

Interventions

  • Bevacizumab Drug
  • Carboplatin Drug
  • Gemcitabine Drug
  • MIRV Drug
  • Paclitaxel Drug
  • Pegylated liposomal doxorubicin (PLD) Drug
  • Sofetabart Mipitecan Drug
  • Topotecan Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 21, 2025
Primary completion
Mar 31, 2028
Completion
Jul 31, 2031
Last update posted
Apr 16, 2026

2025 – 2031

United States locations

U.S. sites
80
U.S. states
34
U.S. cities
70
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 Not yet recruiting
HonorHealth Phoenix Arizona 85016 Not yet recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center Burbank California 91505 Not yet recruiting
City of Hope, Duarte Duarte California 91010 Not yet recruiting
Moores Cancer Center La Jolla California 92093 Not yet recruiting
UCLA Hematology/Oncology - Westwood (Building 100) Los Angeles California 90095 Not yet recruiting
Stanford Women's Cancer Center Palo Alto California 94305 Not yet recruiting
Kaiser Permanente Zion Medical Center San Diego California 92120 Not yet recruiting
Sansum Clinic Santa Barbara California 93105 Recruiting
Kaiser Permanente Vallejo California 94589 Not yet recruiting
Anschutz Cancer Pavilion Aurora Colorado 80045 Not yet recruiting
AdventHealth Medical Group - Porter Denver Colorado 80210 Not yet recruiting
UConn Health Farmington Connecticut 06030-8010 Not yet recruiting
Broward Health Medical Center Fort Lauderdale Florida 33316 Not yet recruiting
Florida Cancer Specialist- South Fort Myers Florida 33901 Not yet recruiting
Baptist MD Anderson Cancer Center Jacksonville Florida 32207 Not yet recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida 33136 Not yet recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach Florida 33140 Not yet recruiting
AdventHealth Orlando Orlando Florida 32803 Not yet recruiting
Moffitt Cancer Center Tampa Florida 33612 Not yet recruiting
Florida Cancer Specialist- East West Palm Beach Florida 33401 Not yet recruiting
Winship Cancer Institute, Emory University Atlanta Georgia 30322 Not yet recruiting
Nancy N. & J.C. Lewis Cancer and Research Pavillion Savannah Georgia 31405 Not yet recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 Not yet recruiting
Illinois Cancer Specialists Arlington Heights Illinois 60005 Recruiting
Northwestern Memorial Hospital Chicago Illinois 60611 Not yet recruiting
Rush University Medical Center Chicago Illinois 60612 Not yet recruiting
OSF Saint Fracis Medical Center Peoria Illinois 61637 Not yet recruiting
Franciscan Health Indianapolis Indiana 46237 Not yet recruiting
Baptist Health Lexington Lexington Kentucky 40503 Not yet recruiting
Norton Women's and Children's Hospital Louisville Kentucky 40207 Not yet recruiting
Ochsner Clinic Foundation New Orleans Louisiana 70121 Not yet recruiting
Trials 365 Shreveport Louisiana 71103 Recruiting
Maine Medical Center - Scarborough Campus Scarborough Maine 04074 Not yet recruiting
Greater Baltimore Medical Center Baltimore Maryland 21204 Not yet recruiting
Sinai Hospital Of Baltimore Baltimore Maryland 21215 Not yet recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts 01605 Not yet recruiting
Karmanos Cancer Institute Detroit Michigan 48201 Not yet recruiting
West Michigan Cancer Center Kalamazoo Michigan 49007 Not yet recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota 55905 Not yet recruiting
University of Missouri Hospital Columbia Missouri 65212 Not yet recruiting
HCA Midwest Kansas City, MidAmerica Division, Inc. Kansas City Missouri 64132 Not yet recruiting
Cox Medical Center North Springfield Missouri 65802 Not yet recruiting
The Center of Hope Reno Nevada 89511 Not yet recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 Not yet recruiting
Holy Name Medical Center Teaneck New Jersey 07666 Not yet recruiting
Optimum Clinical Research Group Albuquerque New Mexico 87109 Not yet recruiting
Roswell Park Cancer Institute Buffalo New York 14263 Not yet recruiting
Northwell Health/ RJ Zuckerberg Cancer Center Lake Success New York 11042 Not yet recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York 11501 Recruiting
Laura and Isaac Perlmutter Cancer Center New York New York 10016 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Not yet recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Levine Cancer Institute Charlotte North Carolina 28204 Not yet recruiting
Duke Cancer Institute Durham North Carolina 27710 Not yet recruiting
Miami Valley Hospital South Centerville Ohio 45459 Recruiting
University of Cincinnati Medical Center Cincinnati Ohio 45219 Not yet recruiting
Oncology Hematology Care Inc Cincinnati Ohio 45242 Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Not yet recruiting
Cleveland Clinic Cleveland Ohio 44195 Not yet recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T Columbus Ohio 43210 Not yet recruiting
The Mark H Zangmeister Center Columbus Ohio 43219 Not yet recruiting
ProMedica Flower Hospital Sylvania Ohio 43560 Not yet recruiting
USO - Oncology Associates of Oregon, P. C. Eugene Oregon 97401 Recruiting
Providence Portland Medical Center Portland Oregon 97213 Not yet recruiting
Kaiser Permanente Interstate Medical Office Central Portland Oregon 97227 Recruiting
Oregon Health and Science University Portland Oregon 97239 Not yet recruiting
University of Pennsylvania Hospital Philadelphia Pennsylvania 19104 Not yet recruiting
Asplundh Cancer Pavilion Willow Grove Pennsylvania 19090 Not yet recruiting
Women & Infants Hospital Providence Rhode Island 02905 Not yet recruiting
Medical University of South Carolina Charleston South Carolina 29425 Not yet recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232 Not yet recruiting
USO-Texas Oncology-Central/South Texas Austin Texas 78731 Recruiting
US Oncology The Woodlands Texas 77380 Recruiting
USO - Texas Oncology Gulf Coast Webster Texas 77598-4420 Recruiting
Huntsman Cancer Institute Salt Lake City Utah 84112 Not yet recruiting
Swedish Cancer Institute - Edmonds Edmonds Washington 98026 Not yet recruiting
Swedish Medical Center Seattle Washington 98104 Not yet recruiting
Fred Hutchinson Cancer Center Seattle Washington 98109 Not yet recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 179 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07213804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2026 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07213804 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →