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A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Jan 13, 2027 → May 3, 2029
See other at-risk trials from Incyte

Record History

  1. Primary and study completion pushed from Jan 13, 2027 to May 3, 2029 Enrollment increased: 408 → 570 participants · Trial sites expanded: 36 → 39 locations · Trial arms changed: 10 → 12 · 1 morev35 Show 4 more changesShow less
    • Enrollment increased: 408 → 570 participants
    • Trial sites expanded: 36 → 39 locations
    • Trial arms changed: 10 → 12
    • Interventions: Cetuximab (Drug), FOLFIRI (Drug), FOLFOX (Drug), INCA33890 (Drug), bevacizumab (Drug) to ADG126 (Drug), Cetuximab (Drug), FOLFIRI (Drug), FOLFOX (Drug), INCA33890 (Drug), bevacizumab (Drug)
  2. Site details revised at 1 of 36 sitesv34
  3. Site details revised at 2 of 36 sitesv33
  4. Site details revised at 2 of 36 sitesv32
  5. Site details revised at 1 of 36 sitesv31
Show 29 earlier versionsHide 29 earlier versions
  1. Re-verified, no change to tracked fieldsv30
  2. Study sites: 35 to 36v29
  3. Study sites: 34 to 35v28
  4. Enrollment target: 245 to 408 Primary endpoints revised (3) · Primary and study completion dates: Dec 24, 2026 to Jan 13, 2027 · Interventions: INCA33890 (Drug) to Cetuximab (Drug), FOLFIRI (Drug), FOLFOX (Drug), INCA33890 (Drug), bevacizumab (Drug) · 4 morev27 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Primary and study completion dates: Dec 24, 2026 to Jan 13, 2027
    • Interventions: INCA33890 (Drug) to Cetuximab (Drug), FOLFIRI (Drug), FOLFOX (Drug), INCA33890 (Drug), bevacizumab (Drug)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (11)
    • Site details revised at 1 of 34 sites
    • Study arms: 2 to 10

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 33 to 34v26
  6. Study sites: 32 to 33v25
  7. Site details revised at 1 of 32 sitesv24
  8. Study sites: 31 to 32v23
  9. Study sites revised (31)v22 See this version in full on ClinicalTrials.gov ↗
  10. Study Status, Referencesv21
  11. Study sites: 30 to 31v20
  12. Study sites revised (30)v19 See this version in full on ClinicalTrials.gov ↗
  13. Enrollment target: 165 to 245 Eligibility criteria expanded, about 5 wordsv18 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  14. Site details revised at 1 of 30 sitesv17
  15. Site details revised at 1 of 30 sitesv16
  16. Site details revised at 1 of 30 sitesv15
  17. Study sites: 31 to 30v14
  18. Site details revised at 2 of 31 sitesv13
  19. Site details revised at 1 of 31 sitesv12
  20. Site details revised at 1 of 31 sitesv11
  21. Eligibility criteria shortened, about 210 words Site details revised at 4 of 31 sitesv10 Show 1 more changeShow less
    • Site details revised at 4 of 31 sites

    See this version in full on ClinicalTrials.gov ↗

  22. Site details revised at 1 of 31 sitesv9
  23. Site details revised at 2 of 31 sitesv8
  24. Site details revised at 1 of 31 sitesv7
  25. Site details revised at 4 of 31 sitesv6
  26. Study sites: 30 to 31v5
  27. Site details revised at 1 of 30 sitesv4
  28. Site details revised at 2 of 30 sitesv3
  29. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 100 to 165 · Primary and study completion dates: May 23, 2026 to Dec 24, 2026 · Study sites: 0 to 30 · 1 morev2 Show 4 more changesShow less
    • Enrollment target: 100 to 165
    • Primary and study completion dates: May 23, 2026 to Dec 24, 2026
    • Study sites: 0 to 30
    • Start date changed from estimate of Jun 23, 2023 to Jul 24, 2023
  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.
Incyte
94 trials monitored
See 9 trials at risk
To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
Trial Details
NCT Number NCT05836324
Lead Sponsor Incyte Corporation
Conditions Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
Enrollment 570 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov