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.
Eli Lilly and Company
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Part A and B: * Have histologically confirmed high-grade serous or high-grade 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 the…
Interventions
- DrugSofetabart Mipitecan
Administered IV
- DrugPaclitaxel
Administered IV
- DrugTopotecan
Administered IV
- DrugGemcitabine
Administered IV
- DrugPegylated liposomal doxorubicin (PLD)
Administered IV
- DrugMIRV
Administered IV
- DrugBevacizumab
Administered IV
Locations (260)
- University of Alabama at BirminghamBirmingham, Alabama
- HonorHealthPhoenix, Arizona
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterBurbank, California
- City of Hope, DuarteDuarte, California
- Moores Cancer CenterLa Jolla, California
- UCLA Hematology/Oncology - Westwood (Building 100)Los Angeles, California