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Study identifier: NCT07213804 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Ovarian Neoplasms · Fallopian Tube Neoplasms · Peritoneal Neoplasms  ·  Sponsor: Eli Lilly and Company

PhasePhase 3
Planned participants1630
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or  ·  1-317-615-4559  ·  LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact  ·  clinical_inquiry_hub@lilly.com

Always discuss trial participation with your own doctor first.

Locations (266)

University of Alabama at BirminghamBirmingham, Alabama, United StatesNot Yet Recruiting
HonorHealthPhoenix, Arizona, United StatesRecruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterBurbank, California, United StatesRecruiting
City of Hope, DuarteDuarte, California, United StatesNot Yet Recruiting
City of Hope LennarIrvine, California, United StatesNot Yet Recruiting
Kaiser Permanente Zion Medical CenterIrvine, California, United StatesRecruiting
Moores Cancer CenterLa Jolla, California, United StatesNot Yet Recruiting
UCLA Hematology/Oncology - Westwood (Building 100)Los Angeles, California, United StatesRecruiting
Stanford Women's Cancer CenterPalo Alto, California, United StatesRecruiting
Sansum ClinicSanta Barbara, California, United StatesRecruiting
Kaiser PermanenteVallejo, California, United StatesNot Yet Recruiting
Anschutz Cancer PavilionAurora, Colorado, United StatesNot Yet Recruiting

+ 254 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07213804