Phase 3 Study of Sofetabart Mipitecan Compared to Chemotherapy or Mirvetuximab Soravtansine for Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Compared to Platinum Chemotherapy Plus Bevacizumab for Platinum-Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancers

What this Trial Is About

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.

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