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
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.
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 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07213804
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,630 participants
Conditions and interventions
Interventions
- Sofetabart Mipitecan Drug
- Paclitaxel Drug
- Topotecan Drug
- Gemcitabine Drug
- Pegylated liposomal doxorubicin (PLD) Drug
- MIRV Drug
- Bevacizumab Drug
- Carboplatin 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
- Oct 31, 2028
- Completion
- Jul 31, 2031
- Last update posted
- Aug 20, 2026
2025 – 2031
United States locations
- U.S. sites
- 87
- U.S. states
- 34
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Not yet recruiting |
| HonorHealth | Phoenix | Arizona | 85016 | Recruiting |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center | Burbank | California | 91505 | Recruiting |
| City of Hope, Duarte | Duarte | California | 91010 | Not yet recruiting |
| City of Hope Lennar | Irvine | California | 92618 | Not yet recruiting |
| Kaiser Permanente Zion Medical Center | Irvine | California | 92618 | Recruiting |
| Moores Cancer Center | La Jolla | California | 92093 | Not yet recruiting |
| UCLA Hematology/Oncology - Westwood (Building 100) | Los Angeles | California | 90095 | Recruiting |
| Stanford Women's Cancer Center | Palo Alto | California | 94305 | 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 | Recruiting |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | Recruiting |
| Florida Cancer Specialist- South | Fort Myers | Florida | 33901 | Recruiting |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | 33136 | Recruiting |
| Mount Sinai Braman Comprehensive Cancer Center | Miami Beach | Florida | 33140 | 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 | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | 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 | Recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Not yet recruiting |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | Not yet recruiting |
| OSF Saint Fracis Medical Center | Peoria | Illinois | 61637 | Recruiting |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | Not yet recruiting |
| Franciscan Health | Indianapolis | Indiana | 46237 | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | Recruiting |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | Not yet recruiting |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | 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 | Recruiting |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | Recruiting |
| Sinai Hospital Of Baltimore | Baltimore | Maryland | 21215 | Recruiting |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | Not yet recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | Recruiting |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | 55905 | Not yet recruiting |
| University of Missouri Hospital | Columbia | Missouri | 65212 | Recruiting |
| HCA Midwest Kansas City, MidAmerica Division, Inc. | Kansas City | Missouri | 64132 | Not yet recruiting |
| Cox Medical Center North | Springfield | Missouri | 65802 | Recruiting |
| The Center of Hope | Reno | Nevada | 89511 | Recruiting |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | 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 | 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 |
| Duke Cancer Institute | Durham | North Carolina | 27710 | 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 |
| Fairview Hospital | Cleveland | Ohio | 44111 | Not yet recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T | Hilliard | Ohio | 43026 | Recruiting |
| Cleveland Clinic - Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | Not yet recruiting |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | Not yet recruiting |
| University of Oklahoma Health Sciences Center, Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Not yet recruiting |
| USO - Oncology Associates of Oregon, P. C. | Eugene | Oregon | 97401 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Kaiser Permanente Interstate Medical Office Central | Portland | Oregon | 97227 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Jefferson Health Honickman Center | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | Recruiting |
| Women & Infants Hospital | Providence | Rhode Island | 02905 | 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 |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Not yet 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 | 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 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | 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 180 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 Aug 20, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07213804 live on ClinicalTrials.gov.