Clinical trial · no report yet · Phase 3
FRAmework-01
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
- NCT07213804 ↗
- Recruiting
- Eli Lilly and Company
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| YouTube | 2 | |
| Podcasts | 2 | |
| X threads | 1 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- FRAmework-01: A Three-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.
- Phase
- Phase 3
- Status
- Recruiting
- Conditions
- Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Neoplasm Metastasis
- Interventions
- Sofetabart Mipitecan; Paclitaxel; Topotecan; Gemcitabine; Pegylated liposomal doxorubicin (PLD); MIRV; Bevacizumab; Carboplatin
- Arms
- Part A: Sofetabart Mipitecan · Experimental
- Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV) · Active comparator
- Part B: Sofetabart Mipitecan plus Bevacizumab · Experimental
- Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab · Active comparator
- Part C: Sofetabart Mipitecan plus Bevacizumab · Experimental
- Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab · Active comparator
- Enrollment
- 1,630 (estimated)
- Primary outcomes
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
- PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)
- Sponsor
- Eli Lilly and Company with GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
- Start
- Oct 22, 2025
- Primary completion
- Nov 2028 (estimated)
- Results posted
- No
- Registry record
- NCT07213804 · updated Oct 8, 2026
Publications
linked from the registry- Ray-Coquard I, O'Malley DM, Oaknin A, Madariaga A, Lakhani N, McKean W, Perez-Fidalgo A, Okera M, Kitano S, Koyama T, Frenel JS, Curigliano G, Khajawa MR, Cheol Lim M, Lorusso D, Pilla Reddy V, Speck RM, Gilligan AM, Szpurka AM, Manvelyan M, Wu Y, Wang C, Avsar E, Friedman CF, Sachdeva D, Kyi C, Pothuri B. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study. Ann Oncol. 2026 Oct 8:S0923-7534(26)06781-5. doi: 10.1016/j.annonc.2026.10.001. Online ahead of print. PubMed 42849725