Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

StatusCompleted
PhasePhase 2
Started

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

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 71 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 14, 2026 Show 7 more changesShow less
    • Interventions: brigimadlin (Drug) to Brigimadlin (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    • Site details revised at 2 of 60 sites
    • Publications: details revised at 1 of 1 entry
    • Study arms: 1 to 4
  2. Trial status: Terminated to Completed
    • Study sites revised (60)
    v70
  3. Trial status: Completed to Terminated
    • Sponsor's reason: Sponsor decision
    • Secondary endpoints: 10 to 6
    • Study sites revised (60)
    v69
  4. Study sites revised (60)v68
  5. Re-verified, no change to tracked fieldsv67
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (60)v66
  2. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Oct 20, 2025 to Sep 25, 2025
    • Study sites revised (60)
    v65
  3. 2 versions Re-verified since Aug 18, 2025, no change to tracked fieldsv63-v64
  4. Study sites: 59 to 60v62
  5. Re-verified, no change to tracked fieldsv61
  6. Study sites: 60 to 59
    • Primary completion date: Jun 10, 2025 to Oct 20, 2025
    v60
  7. Re-verified, no change to tracked fieldsv59
  8. Study sites: 57 to 60v58
  9. Re-verified, no change to tracked fieldsv57
  10. Study sites: 56 to 57
    • Study completion date: Jun 10, 2025 to Oct 20, 2025
    v56
  11. Study sites: 54 to 56v55
  12. Study sites: 49 to 54v54
  13. Study sites: 48 to 49v53
  14. Study sites: 46 to 48v52
  15. Study sites: 45 to 46v51
  16. Re-verified, no change to tracked fieldsv50
  17. Study sites: 43 to 45
    • Primary completion date: Feb 17, 2025 to Jun 10, 2025
    • Study completion date: Nov 25, 2026 to Jun 10, 2025
    v49
  18. Enrollment target: 100 to 99v48
  19. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 103 to confirmed 100
    • Study sites: 42 to 43
    v47
  20. Study sites: 68 to 42v46
  21. Study sites: 63 to 68
    • Start date: Nov 25, 2022 to Dec 13, 2022
    v45
  22. Study sites: 65 to 63v44
  23. Study sites: 66 to 65v43
  24. Study sites: 65 to 66v42
  25. Enrollment target: 155 to 103
    • Study sites: 66 to 65
    v41
  26. Primary completion date: Jun 17, 2025 to Feb 17, 2025
    • Study completion date: Mar 25, 2027 to Nov 25, 2026
    v40
  27. Study sites: 65 to 66v39
  28. Primary completion date: Feb 20, 2025 to Jun 17, 2025v38
  29. Study sites: 63 to 65v37
  30. Study sites: 62 to 63v36
  31. Study sites: 61 to 62v35
  32. Study sites: 59 to 61v34
  33. Study sites: 58 to 59v33
  34. Study sites: 57 to 58v32
  35. Study sites: 53 to 57v31
  36. Study sites: 52 to 53v30
  37. Study sites: 50 to 52v29
  38. Study sites: 48 to 50v28
  39. Study sites: 47 to 48v27
  40. Re-verified, no change to tracked fieldsv26
  41. Study sites: 46 to 47v25
  42. Study sites: 45 to 46v24
  43. Study sites: 41 to 45v23
  44. Study sites: 40 to 41v22
  • 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.
Boehringer Ingelheim
223 trials monitored
See 11 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Pancreatic Cancer
1,740 trials monitored
See 105 trials at risk
Bladder Cancer
1,058 trials monitored
See 76 trials at risk
and 1 more disease
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT05512377
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Pancreatic Neoplasms, Solid Tumors, Biliary Tract Cancer, Lung Neoplasms, Bladder Cancer
Related terms Biliary Tract Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov