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Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 31, 2027 → Nov 30, 2028
See other at-risk trials from Boehringer Ingelheim

Record History

  1. Eligibility criteria expanded, about 14 words Secondary endpoints: details revised at 1 of 6 entries · Study sites revised (92) · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study sites revised (92)
    • Publications: details revised at 1 of 1 entry
  2. Eligibility criteria shortened, about 47 words Study sites revised (92)v48 Show 1 more changeShow less
    • Study sites revised (92)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial sites expanded: 89 → 92 locationsv47
  4. Site details revised at 2 of 89 sitesv46
  5. Study sites: 90 to 89v45
  6. Primary completion pushed from Dec 31, 2027 to Nov 30, 2028 Enrollment increased: 430 → 588 participants · Study sites: 88 to 90v44 Show 2 more changesShow less
    • Enrollment increased: 430 → 588 participants
    • Study sites: 88 to 90
  7. Study sites revised (88)v43 See this version in full on ClinicalTrials.gov ↗
  8. Site details revised at 1 of 88 sitesv42
  9. Site details revised at 1 of 88 sitesv41
  10. Trial sites expanded: 84 → 88 locationsv40
  11. Secondary endpoints revised (6)v39 See this version in full on ClinicalTrials.gov ↗
  12. Study sites: 83 to 84v38
  13. Eligibility criteria shortened, about 11 words Secondary endpoints revised (6) · Study sites revised (83)v37 Show 2 more changesShow less
    • Secondary endpoints revised (6)
    • Study sites revised (83)

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 82 to 83v36
  15. Study sites: 80 to 82v35
  16. Study sites revised (80)v34 See this version in full on ClinicalTrials.gov ↗
  17. Site details revised at 1 of 80 sitesv33
  18. Study sites: 74 to 80v32
  19. Study sites: 73 to 74v31
  20. Study sites: 70 to 73v30
  21. Study sites revised (70)v29 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 67 to 70v28
  23. Study sites revised (67)v27 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (67)v26 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 65 to 67 Primary completion date: Dec 29, 2028 to Dec 31, 2027v25 Show 1 more changeShow less
    • Primary completion date: Dec 29, 2028 to Dec 31, 2027
  26. Enrollment target: 200 to 430 Primary completion date: Sep 2, 2027 to Dec 29, 2028 · Completion date: Nov 30, 2028 to Dec 29, 2028 · Eligibility criteria shortened, about 30 words · 1 morev24 Show 4 more changesShow less
    • Primary completion date: Sep 2, 2027 to Dec 29, 2028
    • Completion date: Nov 30, 2028 to Dec 29, 2028
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  27. Completion date: Sep 30, 2027 to Nov 30, 2028v23
  28. Study sites: 64 to 65v22
  29. Site details revised at 2 of 64 sitesv21
  30. Study sites revised (64)v20 See this version in full on ClinicalTrials.gov ↗
  31. Study sites: 65 to 64v19
  32. Study sites: 41 to 65v18
  33. Study sites revised (41)v17 See this version in full on ClinicalTrials.gov ↗
  34. Study sites: 42 to 41 Eligibility criteria expanded, about 20 wordsv16 Show 1 more changeShow less
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  35. Study sites: 64 to 42v15
  36. Study sites: 65 to 64v14
  37. Site details revised at 3 of 65 sitesv13
  38. Site details revised at 12 of 65 sitesv12
  39. Study sites: 26 to 65v11
  40. Study sites: 29 to 26v10
  41. Study sites: 85 to 29v9
  42. Study sites: 63 to 85v8
  43. Study sites: 18 to 63 Start date: Sep 12, 2024 to Oct 11, 2024v7 Show 1 more changeShow less
    • Start date: Sep 12, 2024 to Oct 11, 2024
  44. Study sites: 15 to 18v6
  45. Study sites: 12 to 15v5
  46. Study sites: 7 to 12v4
  47. Study sites: 2 to 7v3
  48. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Sep 16, 2024 to Sep 12, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 16, 2024 to Sep 12, 2024
  49. 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.
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2. Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it. Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT06581432
Lead Sponsor Boehringer Ingelheim
Conditions Solid Tumours
Enrollment 588 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov