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
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 267 to 265
  2. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised at 32 of 267 sites
  3. Study sites: 268 to 267v25
  4. Trial sites expanded: 265 → 268 locationsv24
  5. Study sites: 266 to 265v23
Show 2 earlier versionsHide 2 earlier versions
  1. Site contacts updated at 20 of 266 sitesv22
  2. Study sites: 265 to 266v21
  1. Trial sites expanded: 261 → 265 locationsv20
  2. Primary completion pushed from Apr 2028 to Nov 2028v19 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 1080 → 1630 participants
    • Trial arms changed: 4 → 6
    • Study sites: 259 to 261
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 12 to 13
    • Study title expanded, about 1 word
  3. Site contacts updated at 18 of 259 sitesv18
  4. Study sites: 258 to 259v17
  5. Study sites: 260 to 258v16
  6. Trial sites expanded: 254 → 260 locationsv15
  7. Study sites: 251 to 254v14
  8. Study sites: 249 to 251v13
  9. Study sites: 245 to 249v12
  10. Study sites: 219 to 245v11
  11. Study sites: 209 to 219v10 Show 4 more changesShow less
    • Interventions: Bevacizumab (Drug), Carboplatin (Drug), Gemcitabine (Drug), LY4170156 (Drug), MIRV (Drug), Paclitaxel (Drug), Pegylated liposomal… to Bevacizumab (Drug), Carboplatin (Drug), Gemcitabine (Drug), MIRV (Drug), Paclitaxel (Drug), Pegylated liposomal doxorubicin (PLD) (Drug)…
    • Secondary endpoints revised (12)
    • Eligibility criteria expanded, about 3 words
    • Study title expanded, about 2 words
  12. Study sites: 137 to 209v9
  13. Re-verified, no change to tracked fieldsv8
  14. Site contacts updated at 11 of 137 sitesv7
  15. Study sites: 96 to 137v6
  16. Study sites: 68 to 96v5
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2025 to Oct 22, 2025
    • Site details revised at 68 of 68 sites
    v4
  18. Study sites: 39 to 68v3
  19. Study sites: 32 to 39v2
  20. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
366 trials monitored
See 16 trials at risk
Ovarian Cancer
1,347 trials monitored
See 96 trials at risk
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.
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
(from sponsor)		 Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis
Related terms Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms
Enrollment 1,630 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov