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A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 63 to 64
  2. Notable Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Trial sites expanded: 54 → 63 locations · Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 6 of 16 entries Show 3 more changesShow less
    • Trial sites expanded: 54 → 63 locations
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 6 of 16 entries
  3. Minor Trial sites reduced: 63 → 54 locationsv38
  4. Minor Study sites: 61 to 63 Eligibility criteria shortened, about 1 wordv37 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Study sites: 60 to 61v36
  6. Minor Study sites: 59 to 60v35
  7. Minor Trial sites expanded: 56 → 59 locationsv34
  8. Minor Study sites: 54 to 56v33
  9. Minor Study sites: 52 to 54v32
  10. Minor Study sites: 50 to 52v31
  11. Minor Study sites: 49 to 50v30
  12. Minor Study sites: 48 to 49v29
  13. Minor Re-verified, no change to tracked fieldsv28
  14. Minor Study sites: 47 to 48v27
  15. Minor Study sites: 46 to 47v26
  16. Minor Study sites: 43 to 46v25
  17. Minor Study sites: 42 to 43v24
  18. Minor Study sites: 40 to 42v23
  19. Minor Study sites: 38 to 40v22
  20. Minor Study sites: 31 to 38v21
  21. Minor Study description revisedv20 See this version in full on ClinicalTrials.gov ↗
  22. Minor Study sites: 28 to 31 Eligibility criteria expanded, about 8 wordsv19 Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  23. Minor Study sites: 27 to 28v18
  24. Minor Study sites: 26 to 27v17
  25. Minor Study sites: 25 to 26v16
  26. Minor Study sites: 23 to 25v15
  27. Minor Study sites: 22 to 23v14
  28. Minor Study sites: 21 to 22v13
  29. Minor Study sites: 20 to 21v12
  30. Minor Study sites: 18 to 20v11
  31. Minor Study sites: 17 to 18v10
  32. Minor Study sites: 14 to 17v9
  33. Minor Study sites: 11 to 14v8
  34. Minor Study sites: 10 to 11v7
  35. Minor Study sites: 7 to 10v6
  36. Minor Study sites: 4 to 7v5
  37. Minor Study sites: 2 to 4v4
  38. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jun 12, 2025 to May 26, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 12, 2025 to May 26, 2025
  39. Minor Start date: May 22, 2025 to Jun 12, 2025 Secondary endpoints: details revised at 1 of 16 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 16 entries
  40. Minor 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.
407 trials monitored
See 29 trials at risk
Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of HER3-DXd in children and if they tolerate it * What happens to HER3-DXd in children's bodies over time * If children who receive HER3-DXd have the cancer get smaller or go away
Trial Details
NCT Number NCT06941272
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Malignant Neoplasm
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov