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Anti-GD2 ADC M3554 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Notable Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Enrollment increased: 52 → 65 participants · Eligibility criteria expanded, about 10 words · Site details revised at 3 of 11 sites Show 3 more changesShow less
    • Enrollment increased: 52 → 65 participants
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 3 of 11 sites
  3. Minor Eligibility criteria revisedv22 See this version in full on ClinicalTrials.gov ↗
  4. Minor Site details revised at 1 of 11 sites Collaborator revisedv21 Show 1 more changeShow less
  5. Minor 3 versions Re-verified since May 7, 2026, no change to tracked fieldsv18-v20
  6. Minor Primary completion pushed from Oct 27, 2026 to Apr 16, 2027v17
  7. Minor Re-verified, no change to tracked fieldsv16
  8. Minor Site details revised at 1 of 11 sitesv15
  9. Minor Primary completion date: Mar 27, 2027 to Oct 27, 2026 Completion date: Mar 27, 2028 to Apr 16, 2027 · Site details revised at 2 of 11 sitesv14 Show 2 more changesShow less
    • Completion date: Mar 27, 2028 to Apr 16, 2027
    • Site details revised at 2 of 11 sites
  10. Minor Study sites: 9 to 11v13
  11. Minor Re-verified, no change to tracked fieldsv12
  12. Minor Eligibility criteria shortened, about 57 wordsv11 See this version in full on ClinicalTrials.gov ↗
  13. Notable Primary completion date: Apr 10, 2026 to Mar 27, 2027 Completion date: Oct 27, 2027 to Mar 27, 2028v10 Show 1 more changeShow less
    • Completion date: Oct 27, 2027 to Mar 27, 2028
  14. Minor Primary completion date: Sep 20, 2026 to Apr 10, 2026 Completion date: Sep 20, 2026 to Oct 27, 2027 · Site details revised at 2 of 9 sitesv9 Show 2 more changesShow less
    • Completion date: Sep 20, 2026 to Oct 27, 2027
    • Site details revised at 2 of 9 sites
  15. Minor 2 versions Re-verified since Apr 2, 2025, no change to tracked fieldsv7-v8
  16. Minor Site details revised at 1 of 9 sitesv6
  17. Minor Site details revised at 2 of 9 sitesv5
  18. Minor Site details revised at 1 of 9 sitesv4
  19. Minor Collaborator revisedv3 See this version in full on ClinicalTrials.gov ↗
  20. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 9 · Start date changed from estimate of Nov 1, 2024 to Nov 8, 2024v2 Show 2 more changesShow less
    • Study sites: 2 to 9
    • Start date changed from estimate of Nov 1, 2024 to Nov 8, 2024
  21. 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.
43 trials monitored
See 4 trials at risk
The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months
Trial Details
NCT Number NCT06641908
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Advanced Solid Tumor
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov