Trials / Recruiting
RecruitingNCT07213804
A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
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.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,080 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sofetabart Mipitecan | Administered IV |
| DRUG | Paclitaxel | Administered IV |
| DRUG | Topotecan | Administered IV |
| DRUG | Gemcitabine | Administered IV |
| DRUG | Pegylated liposomal doxorubicin (PLD) | Administered IV |
| DRUG | MIRV | Administered IV |
| DRUG | Bevacizumab | Administered IV |
| DRUG | Carboplatin | Administered IV |
Timeline
- Start date
- 2025-10-22
- Primary completion
- 2028-04-01
- Completion
- 2031-08-01
- First posted
- 2025-10-09
- Last updated
- 2026-04-17
Locations
260 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07213804. Inclusion in this directory is not an endorsement.