{"preliminary_commentary":{"by_channel":{"youtube":2,"podcast":2,"x_thread":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"FRAmework-01","nct_id":"NCT07213804","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=framework-01-nct07213804. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"FRAmework-01","arms":[{"description":"Administered intravenously (IV).","label":"Part A: Sofetabart Mipitecan","type":"EXPERIMENTAL"},{"description":"Investigator's Choice of Chemotherapy or MIRV given IV.","label":"Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)","type":"ACTIVE_COMPARATOR"},{"description":"Administered IV.","label":"Part B: Sofetabart Mipitecan plus Bevacizumab","type":"EXPERIMENTAL"},{"description":"Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.","label":"Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab","type":"ACTIVE_COMPARATOR"},{"description":"Administered IV","label":"Part C: Sofetabart Mipitecan plus Bevacizumab","type":"EXPERIMENTAL"},{"description":"Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.","label":"Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab","type":"ACTIVE_COMPARATOR"}],"collaborators":["GOG Foundation","European Network of Gynaecological Oncological Trial Groups (ENGOT)","Asia-Pacific Gynecologic Oncology Trials Group"],"completion_date":{"date":"2031-08","type":"ESTIMATED"},"conditions":["Ovarian Neoplasms","Fallopian Tube Neoplasms","Peritoneal Neoplasms","Neoplasm Metastasis"],"enrollment":{"count":1630,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Sofetabart Mipitecan","otherNames":["LY4170156","Sofe-M"],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"type":"DRUG"},{"name":"Topotecan","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Pegylated liposomal doxorubicin (PLD)","otherNames":[],"type":"DRUG"},{"name":"MIRV","otherNames":[],"type":"DRUG"},{"name":"Bevacizumab","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-08","lead_sponsor":"Eli Lilly and Company","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.","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-11","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator","timeFrame":"Randomization to radiographic progression or death from any cause (up to 70 months)"},{"measure":"PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)","timeFrame":"Randomization to radiographic progression or death from any cause (up to 70 months)"}],"references":[{"citation":"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.","pmid":"42849725","type":"DERIVED"}],"start_date":{"date":"2025-10-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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","url":"https://clinicaltrials.gov/study/NCT07213804"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/framework-01-nct07213804"}