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
← catalyst calendarNCT07213804 · readout ≤ 833 d
Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →. With GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,630estimated
Sites
265
Countries
Australia, Austria, Belgium +23
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-22 | actual | When the study began enrolling |
| Primary completion | Nov 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Neoplasm Metastasis
Interventions
- Drug: Sofetabart Mipitecan — also filed as LY4170156, Sofe-M
- Drug: Paclitaxel
- Drug: Topotecan
- Drug: Gemcitabine
- Drug: Pegylated liposomal doxorubicin (PLD)
- Drug: MIRV
- Drug: Bevacizumab
- Drug: Carboplatin
Primary outcomes
what the primary-completion date above is the date OFProgression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
measured Randomization to radiographic progression or death from any cause (up to 70 months)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)
measured Randomization to radiographic progression or death from any cause (up to 70 months)
Permalink · LLY's whole pipeline · Catalyst calendar · Every registered study · What changed