A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Study acronym: NEXUS-01
StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 4
    • Enrollment target: 420 to 460
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 7 words
  2. Study sites: 39 to 40
    • Eligibility criteria expanded, about 27 words
  3. Site details revised at 1 of 39 sitesv37
  4. Site details revised at 1 of 39 sitesv36
  5. Study sites: 38 to 39v35
  6. Site details revised at 1 of 38 sitesv34
  7. Trial sites expanded: 35 → 38 locationsv33
  8. Study sites: 34 to 35v32
  9. Study sites: 33 to 34v31
  10. Site details revised at 1 of 33 sitesv30
  11. Study sites: 31 to 33v29
  12. Site details revised at 1 of 31 sitesv28
  13. Trial sites expanded: 28 → 31 locationsv27
  14. Study sites revised (28)v26
  15. Site details revised at 1 of 28 sitesv25
  16. Site details revised at 1 of 28 sitesv24
  17. Study sites: 27 to 28v23
  18. Study sites: 26 to 27v22
  19. 2 versions Re-verified since Sep 24, 2025, no change to tracked fieldsv20-v21
  20. Study sites: 24 to 26v19
  21. Trial status: Suspended to Recruiting
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 24 of 24 sites
    v18
  22. Trial status: Recruiting to Suspended Sponsor's reason: The study was paused due to sponsor decision.
    • Site details revised at 24 of 24 sites
    v17
  23. Study sites: 16 to 24v16
  24. Site details revised at 1 of 16 sitesv15
  25. Enrollment target: 220 to 420
    • Eligibility criteria expanded, about 1 word
    v14
  26. Study sites: 15 to 16v13
  27. Study description expanded, about 25 wordsv12
  28. Study sites: 12 to 15v11
  29. Study sites: 7 to 12v10
  30. Collaborators shortened, about 3 wordsv9
  31. Study sites: 6 to 7v8
  32. Study sites: 4 to 6v7
  33. Study sites: 3 to 4v6
  34. Study sites: 2 to 3v5
  35. Study Status, Contacts/Locations, Referencesv4
  36. Study sites: 1 to 2v3
  37. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Jul 1, 2024
    • Site details revised
    v2
  38. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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
363 trials monitored
See 16 trials at risk
Breast Cancer
5,455 trials monitored
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Lung Cancer
4,798 trials monitored
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Non-Small Cell Lung Cancer (NSCLC)
3,085 trials monitored
See 178 trials at risk
and 8 more diseases
The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
Trial Details
NCT Number NCT06465069
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer +6 more
Related terms Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Ureteral Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms, Uterine Cervical Neoplasms
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov