A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
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. Trial sites expanded: 47 → 55 locations
  2. Eligibility criteria expanded, about 114 words
  3. Trial sites expanded: 43 → 47 locations
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 3 of 11 entries
  4. Trial sites expanded: 38 → 43 locationsv39
  5. Trial sites expanded: 29 → 38 locationsv38
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 4 of 29 sitesv37
  2. Site details revised at 5 of 29 sitesv36
  1. Trial sites expanded: 25 → 29 locationsv35 Show 5 more changesShow less
    • Trial arms changed: 3 → 4
    • Enrollment target: 295 to 280
    • Interventions: Pembrolizumab (Drug), VVD-133214 (Drug) to Bevacizumab (Drug), Pembrolizumab (Drug), VVD-133214 (Drug)
    • Eligibility criteria expanded, about 91 words
    • Study title shortened, about 2 words
  2. Re-verified, no change to tracked fieldsv34
  3. Site details revised at 2 of 25 sitesv33
  4. Lead sponsor: Hoffmann-La Roche to Vividion Therapeutics, Inc.v32 Show 5 more changesShow less
    • Interventions: Pembrolizumab (Drug), RO7589831 (Drug) to Pembrolizumab (Drug), VVD-133214 (Drug)
    • Secondary endpoints revised (11)
    • Study sites revised (25)
    • Study title revised
    • Eligibility criteria expanded, about 5 words
  5. Site details revised at 2 of 25 sitesv31
  6. Study sites revised (25)v30
  7. Site details revised at 12 of 25 sitesv29
  8. 2 versions Re-verified since Jun 3, 2025, no change to tracked fieldsv27-v28
  9. Study sites revised (25)v26
  10. Study sites: 21 to 25v25
  11. Primary and study completion dates: Dec 15, 2027 to May 31, 2027
    • Site details revised at 1 of 21 sites
    v24
  12. Study sites revised (21)v23
  13. Study sites: 20 to 21v22
  14. Re-verified, no change to tracked fieldsv21
  15. Enrollment target: 220 to 295v20 Show 4 more changesShow less
    • Interventions: RO7589831 (Drug) to Pembrolizumab (Drug), RO7589831 (Drug)
    • Eligibility criteria expanded, about 118 words
    • Study title expanded, about 7 words
    • Study arms: 2 to 3
  16. Primary and study completion dates pushed to Dec 15, 2027
    • Site details revised at 1 of 20 sites
    v19
  17. Site details revised at 1 of 20 sitesv18
  18. Study sites: 19 to 20v17
  19. Site details revised at 1 of 19 sitesv16
  20. Study sites: 18 to 19v15
  21. Study sites: 14 to 18v14
  22. Study sites: 10 to 14v13
  23. Study sites: 8 to 10v12
  24. Study sites: 4 to 8v11
  25. Start date changed from estimate of Feb 29, 2024 to Jan 25, 2024v10
  26. Re-verified, no change to tracked fieldsv9
  27. Start date: Dec 29, 2023 to Feb 29, 2024
    • Study sites: 3 to 4
    v8
  28. Study sites: 2 to 3v7
  29. Re-verified, no change to tracked fieldsv6
  30. Start date: Oct 31, 2023 to Dec 29, 2023v5
  31. Start date: Oct 15, 2023 to Oct 31, 2023v4
  32. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v3
  33. Re-verified, no change to tracked fieldsv2
  34. 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.
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.
Trial Details
NCT Number NCT06004245
Lead Sponsor Vividion Therapeutics, Inc.
Conditions
(from sponsor)		 Advanced Solid Tumors, Colorectal Cancer
Related terms Colorectal Neoplasms, Microsatellite Instability
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov