A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Feb 2027 → Jun 2029
Primary endpoint added 6 → 7 primary endpoints
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Record History

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  1. Study sites: 24 to 25
    • Eligibility criteria expanded, about 13 words
  2. Primary and study completion dates pushed to Jun 2029v26 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 495 → 575 participants
    • Interventions modified
    • Trial arms changed: 9 → 11
    • Study sites: 23 to 24
    • Secondary endpoints: 14 to 15
    • Study title revised
    • Eligibility criteria expanded, about 4 words
  3. Study sites revised (23)v25
  4. Site details revised at 1 of 23 sitesv24
  5. 2 versions Re-verified since Dec 10, 2025, no change to tracked fieldsv22-v23
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 24 to 23v21
  2. Primary endpoints: 4 to 6v20 Show 6 more changesShow less
    • Enrollment target: 360 to 495
    • Interventions: Bevacizumab (Drug), LY4170156 (Drug), carboplatin (Drug) to Itraconazole (Drug), LY4170156 (Drug), bevacizumab (Drug), carboplatin (Drug), pembrolizumab (Drug)
    • Secondary endpoints: 13 to 14
    • Site details revised at 3 of 24 sites
    • Study arms: 6 to 9
    • Eligibility criteria expanded, about 4 words
  3. Study sites: 16 to 24v19
  4. Start date: May 6, 2024 to May 20, 2024v18
  5. Eligibility criteria revisedv17
  6. Enrollment target: 220 to 360v16 Show 5 more changesShow less
    • Primary endpoints: 3 to 4
    • Interventions: LY4170156 (Drug) to Bevacizumab (Drug), LY4170156 (Drug), carboplatin (Drug)
    • Secondary endpoints: 7 to 13
    • Site details revised at 1 of 16 sites
    • Study arms: 3 to 6
  7. Re-verified, no change to tracked fieldsv15
  8. Study sites: 15 to 16v14
  9. Study sites: 14 to 15v13
  10. Study sites: 13 to 14v12
  11. Study sites: 12 to 13v11
  12. Collaborators shortened, about 3 wordsv10
  13. Study sites: 8 to 12v9
  14. Study sites: 6 to 8v8
  15. Study sites: 4 to 6v7
  16. Re-verified, no change to tracked fieldsv6
  17. Study sites: 2 to 4v5
  18. Study sites: 1 to 2v4
  19. Study Status, Referencesv3
  20. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to May 6, 2024
    • Site details revised
    v2
  1. 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
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Breast Cancer
5,486 trials monitored
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Lung Cancer
4,822 trials monitored
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Colorectal Cancer
3,420 trials monitored
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and 6 more diseases
The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
Trial Details
NCT Number NCT06400472
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms
Related terms Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms
Enrollment 575 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov