Clinical Trial

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

Study acronym: FRAmework-01

Recruiting Phase 3

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.

Protocol Amendment History 6 changes

notable Trial sites expanded: 261 -> 265 locations 2026-07-08

critical Primary endpoint(s) modified 2026-06-16

notable Enrollment increased: 1080 -> 1630 participants 2026-06-16

minor Trial arms changed: 4 -> 6 2026-06-16

notable Primary completion pushed: 2028-04 -> 2028-11 2026-06-16

notable Trial sites expanded: 254 -> 260 locations 2026-04-18

Trial Details

NCT Number	NCT07213804
Lead Sponsor	Eli Lilly and Company Collaborators: GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
Conditions	Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis
Enrollment	1,630 participants
Start Date	2025-10-22
Primary Completion	2028-11 (estimated)
Study Completion	2031-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-06