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

StatusRecruiting
PhasePhase 1/2
Started

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

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 28 → 32 locations
  2. Minor Study sites: 28 to 29
  3. Minor Study sites: 26 to 28
  4. Notable Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Show 4 more changesShow less
    • Primary endpoints: details revised at 4 of 6 entries
    • Study sites: 25 to 26
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 8 of 16 entries
  5. Minor Study sites: 23 to 25v11
  6. Minor Trial sites expanded: 20 → 23 locationsv10
  7. Minor Re-verified, no change to tracked fieldsv9
  8. Minor Start date: Jul 2, 2026 to Jul 6, 2026v8
  9. Minor Study sites: 18 to 20v7
  10. Minor Study sites: 17 to 18v6
  11. Minor Trial sites expanded: 14 → 17 locationsv5
  12. Notable Recruitment opened
    • Trial sites expanded: 0 → 14 locations
    • Start date changed from estimate of Jul 28, 2026 to Jul 2, 2026
    v4
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 14
    v3
  14. Minor Re-verified, no change to tracked fieldsv2
  15. Minor 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.
410 trials monitored
See 27 trials at risk
Researchers are looking for new ways to treat children with relapsed or refractory solid tumors: * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids The study treatment I-DXd (also known as MK-2400 or ifinatamab 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 I-DXd and if children younger than 12 years old tolerate it * How many children who receive I-DXd have the cancer get smaller or go away
Trial Details
NCT Number NCT07630974
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)
Malignant Neoplasm
Related terms Neoplasms
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov