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
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.
Eli Lilly and Company
1,630 participants
Oct 22, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Locations(261)
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NCT07213804