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M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Jun 25, 2026, no change to tracked fieldsv21-v22
  2. Notable Enrollment reduced: 141 → 60 participantsv20
  3. Minor Re-verified, no change to tracked fieldsv19
  4. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 20 of 20 sitesv18 Show 1 more changeShow less
    • Site details revised at 20 of 20 sites
  5. Minor 2 versions Re-verified since Oct 16, 2025, no change to tracked fieldsv16-v17
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Study sites: 19 to 20v15
  2. Notable Primary completion date: Mar 9, 2026 to Feb 22, 2027 Primary endpoints: 5 to 6 · Enrollment target: 96 to 141 · Completion date: Mar 26, 2026 to Feb 22, 2027 · 2 morev14 Show 5 more changesShow less
    • Primary endpoints: 5 to 6
    • Enrollment target: 96 to 141
    • Completion date: Mar 26, 2026 to Feb 22, 2027
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 8 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 18 to 19v13
  4. Minor Study sites: 15 to 18v12
  5. Minor Study sites: 12 to 15v11
  6. Minor Study sites: 10 to 12v10
  7. Minor Study sites: 9 to 10v9
  8. Minor Re-verified, no change to tracked fieldsv8
  9. Minor Enrollment target: 90 to 96 Study sites: 4 to 9 · Study title expanded, about 2 wordsv7 Show 2 more changesShow less
    • Study sites: 4 to 9
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Notable Primary endpoints: 3 to 5 Enrollment target: 70 to 90 · Study sites: 2 to 4 · Interventions: M9466 (Drug), Tuvusertib (Drug) to Abiraterone acetate (Drug), M9466 (Drug), Prednisone/Prednisolone (Drug), Tuvusertib (Drug) · 4 morev6 Show 7 more changesShow less
    • Enrollment target: 70 to 90
    • Study sites: 2 to 4
    • Interventions: M9466 (Drug), Tuvusertib (Drug) to Abiraterone acetate (Drug), M9466 (Drug), Prednisone/Prednisolone (Drug), Tuvusertib (Drug)
    • Eligibility criteria expanded, about 141 words
    • Secondary endpoints: 7 to 8
    • Study title shortened, about 6 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  11. Minor Study sites: 1 to 2v5
  12. Minor Re-verified, no change to tracked fieldsv4
  13. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 1 · Start date: Aug 2, 2024 to Aug 7, 2024v3 Show 2 more changesShow less
    • Study sites: 2 to 1
    • Start date: Aug 2, 2024 to Aug 7, 2024
  14. Notable Start date: Jul 1, 2024 to Aug 2, 2024v2
  1. 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 evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
Trial Details
NCT Number NCT06421935
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Advanced Solid Tumor
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov