Summary
This clinical trial is testing a targeted medicine called Sofetabart Mipitecan (Sofe-M) in people with certain types of ovarian, peritoneal, or fallopian tube cancer.
The study has three parts and includes people whose cancer has returned or continued to grow after previous treatment with platinum-based chemotherapy.
Part A (Platinum-resistant cancer)
This part is for people whose cancer became worse during treatment or within six months of finishing platinum chemotherapy. Participants will be randomly assigned (by chance) to receive either
- Sofe-M, or
- The study doctor will choose either standard chemotherapy or mirvetuximab soravtansine (MIRV)
Parts B and C (Platinum-sensitive cancer)
These parts will enrol people whose cancer responded to platinum chemotherapy and remained under control for at least six months after treatment ended. Participants will be randomly assigned to receive either:
- Sofe-M plus bevacizumab
- Platinum-based doublet chemotherapy plus bevacizumab
Researchers want to find out whether Sofe-M works better than the current standard treatments used for these cancers, and learn more about its safety and possible side effects.
Conditions
This trial is treating people with high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer