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 · FRAmework-01 Phase 3Recruiting
- Lead sponsor
- Eli Lilly and Company (Industry)
- Enrollment
- 1,630 (estimated)
- Start date
- 22 Oct 2025
- Primary completion
- Nov 2028 (estimated)
- Study completion
- 1 Aug 2031
- Last update posted
- 8 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 6
Interventions
- Sofetabart Mipitecan Drug
- Paclitaxel Drug
- Topotecan Drug
- Gemcitabine Drug
- Pegylated liposomal doxorubicin (PLD) Drug
- MIRV Drug
- Bevacizumab Drug
- Carboplatin Drug
Conditions and primary outcome
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Neoplasm Metastasis
Primary outcome
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator (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) (Randomization to radiographic progression or death from any cause (up to 70 months))
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedSofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study.
Annals of oncology : official journal of the European Society for Medical Oncology · 2026 Oct 8
PubMed 42849725 (opens in a new tab)DOI 10.1016/j.annonc.2026.10.001 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07213804 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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