Home › Ovarian Cancer › NCT07213804
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
- Sofetabart Mipitecan (drug)
- Paclitaxel (drug)
- Topotecan (drug)
- Gemcitabine (drug)
- Pegylated liposomal doxorubicin (PLD) (drug)
- MIRV (drug)
Sponsor: Eli Lilly and Company · Participants: 1,630 · Started: Oct 22, 2025
Contact the study team
- Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07213804
Locations in the U.S.
| Alabama | University of Alabama at Birmingham, Birmingham (Not yet recruiting) |
| Arizona | HonorHealth, Phoenix |
| California | Roy 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) |
| Colorado | Anschutz Cancer Pavilion, Aurora AdventHealth Medical Group - Porter, Denver (Not yet recruiting) |
| Connecticut | UConn Health, Farmington |
| Florida | Broward 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 |
| Georgia | Winship Cancer Institute, Emory University, Atlanta Nancy N. & J.C. Lewis Cancer and Research Pavillion, Savannah (Not yet recruiting) |
| Hawaii | Kapiolani Medical Center for Women and Children, Honolulu (Not yet recruiting) |
| Illinois | Illinois 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 |
| Indiana | Franciscan Health, Indianapolis Indiana University Melvin and Bren Simon Cancer Center, Indianapolis (Not yet recruiting) |
| Kentucky | Baptist Health Lexington, Lexington Norton Women's and Children's Hospital, Louisville |
| Louisiana | Ochsner Clinic Foundation, New Orleans (Not yet recruiting) Trials 365, Shreveport |
| Maine | Maine Medical Center - Scarborough Campus, Scarborough |
| Maryland | Greater Baltimore Medical Center, Baltimore Sinai Hospital Of Baltimore, Baltimore |
| Massachusetts | University of Massachusetts Chan Medical School, Worcester (Not yet recruiting) |
| Michigan | Karmanos Cancer Institute, Detroit West Michigan Cancer Center, Kalamazoo |
| Minnesota | Mayo Clinic in Rochester, Minnesota, Rochester (Not yet recruiting) |
| Missouri | University of Missouri Hospital, Columbia HCA Midwest Kansas City, MidAmerica Division, Inc., Kansas City (Not yet recruiting) Cox Medical Center North, Springfield |
| Nevada | The Center of Hope, Reno |
| New Hampshire | Dartmouth-Hitchcock Medical Center, Lebanon |
| New Mexico | Optimum Clinical Research Group, Albuquerque (Not yet recruiting) |
| New York | Roswell 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 Carolina | Duke Cancer Institute, Durham |
| Ohio | Miami 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) |
| Oklahoma | University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City (Not yet recruiting) |
| Oregon | USO - 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 |
| Pennsylvania | Jefferson Health Honickman Center, Philadelphia University of Pennsylvania Hospital, Philadelphia Asplundh Cancer Pavilion, Willow Grove |
| Rhode Island | Women & Infants Hospital, Providence |
| South Carolina | Medical University of South Carolina, Charleston (Not yet recruiting) |
| Tennessee | Vanderbilt University Medical Center, Nashville |
| Texas | USO-Texas Oncology-Central/South Texas, Austin UT Southwestern Medical Center, Dallas (Not yet recruiting) US Oncology, The Woodlands USO - Texas Oncology Gulf Coast, Webster |
| Utah | Huntsman Cancer Institute, Salt Lake City |
| Washington | Swedish Cancer Institute - Edmonds, Edmonds Fred Hutchinson Cancer Center, Seattle Swedish Medical Center, Seattle |
| Wisconsin | University 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.