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Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 30, 2026 → Nov 30, 2026
See other at-risk trials from Merck KGaA

Record History

  1. Primary and study completion pushed from Jul 30, 2026 to Nov 30, 2026v37
  2. Primary and study completion moved earlier from Jan 30, 2027 to Jul 30, 2026v36
  3. Primary and study completion dates: Jan 30, 2026 to Jan 30, 2027v35
  4. 4 versions Re-verified since Feb 21, 2025, no change to tracked fieldsv31-v34
  5. Primary and study completion dates: Jan 30, 2025 to Jan 30, 2026v30
Show 28 earlier versionsHide 28 earlier versions
  1. Enrollment target: estimated 204 to confirmed 161v29
  2. Primary completion date: May 20, 2024 to Jan 30, 2025 Completion date: Jul 19, 2024 to Jan 30, 2025v28 Show 1 more changeShow less
    • Completion date: Jul 19, 2024 to Jan 30, 2025
  3. Primary endpoints revised (13) Trial status: Recruiting to Active, Not Recruiting · Study sites: 18 to 16 · Primary completion date: Mar 14, 2024 to May 20, 2024 · 3 morev27 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 16
    • Primary completion date: Mar 14, 2024 to May 20, 2024
    • Completion date: Apr 24, 2024 to Jul 19, 2024
    • Secondary endpoints revised (82)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv25-v26
  5. Site details revised at 9 of 18 sitesv24
  6. Enrollment target: 130 to 204 Site details revised at 5 of 18 sites · Eligibility criteria expanded, about 3 wordsv23 Show 2 more changesShow less
    • Site details revised at 5 of 18 sites
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Primary completion date: Mar 31, 2023 to Mar 14, 2024 Primary endpoints: 12 to 13 · Study sites: 4 to 18 · Completion date: Dec 31, 2023 to Apr 24, 2024 · 3 morev22 Show 6 more changesShow less
    • Primary endpoints: 12 to 13
    • Study sites: 4 to 18
    • Completion date: Dec 31, 2023 to Apr 24, 2024
    • Eligibility criteria expanded, about 192 words
    • Secondary endpoints: 84 to 82
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  8. 5 versions Re-verified since Nov 9, 2021, no change to tracked fieldsv17-v21
  9. Primary completion date: Sep 13, 2021 to Mar 31, 2023v16
  10. 2 versions Re-verified since Jul 7, 2021, no change to tracked fieldsv14-v15
  11. Enrollment target: 24 to 130 Primary endpoints: 10 to 12 · Completion date: Sep 13, 2021 to Dec 31, 2023 · Interventions: M1774 (Drug) to M1774 (Drug), Niraparib (Drug) · 4 morev13 Show 7 more changesShow less
    • Primary endpoints: 10 to 12
    • Completion date: Sep 13, 2021 to Dec 31, 2023
    • Interventions: M1774 (Drug) to M1774 (Drug), Niraparib (Drug)
    • Eligibility criteria expanded, about 199 words
    • Secondary endpoints: 41 to 84
    • Study arms: 3 to 5
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  12. 3 versions Re-verified since Oct 21, 2020, no change to tracked fieldsv10-v12
  13. Site details revised at 1 of 4 sitesv9
  14. Re-verified, no change to tracked fieldsv8
  15. Study sites: 5 to 4v7
  16. 3 versions Re-verified since Apr 6, 2020, no change to tracked fieldsv4-v6
  17. Site details revised at 2 of 5 sitesv3
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 5 · Start date changed from estimate of Nov 19, 2019 to Dec 20, 2019v2 Show 2 more changesShow less
    • Study sites: 2 to 5
    • Start date changed from estimate of Nov 19, 2019 to Dec 20, 2019
  1. 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.
Merck KGaA
43 trials monitored
See 4 trials at risk
This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib.
Trial Details
NCT Number NCT04170153
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Metastatic or Locally Advanced Unresectable Solid Tumors
Enrollment 161 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov