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A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

Study acronym: OrigAMI-1
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 59 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Oct 31, 2030 to May 11, 2031 · Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 1 of 8 entries Show 3 more changesShow less
    • Completion pushed from Oct 31, 2030 to May 11, 2031
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Site details revised at 1 of 53 sitesv58
  3. Site details revised at 1 of 53 sitesv57
  4. Site details revised at 4 of 53 sitesv56
  5. Site details revised at 1 of 53 sitesv55
Show 45 earlier versionsHide 45 earlier versions
  1. 3 versions Re-verified since Jan 15, 2026, no change to tracked fieldsv52-v54
  2. Completion date: Oct 31, 2031 to Oct 31, 2030v51
  3. Re-verified, no change to tracked fieldsv50
  4. Eligibility criteria shortened, about 7 wordsv49 See this version in full on ClinicalTrials.gov ↗
  5. Completion date: May 21, 2029 to Oct 31, 2031v48
  6. Interventions: Amivantamab (Drug), Fluorouracil (Biological), Irinotecan (Biological), Leucovorin (Biological), Oxaliplatin (Biological) to Amivantamab (Biological), Amivantamab IV (Biological), Fluorouracil (Biological), Irinotecan (Biological), Leucovorin (Biological)… Site details revised at 1 of 53 sites · Study arms: 3 to 4v47 Show 2 more changesShow less
    • Site details revised at 1 of 53 sites
    • Study arms: 3 to 4
  7. Re-verified, no change to tracked fieldsv46
  8. Completion date: Apr 27, 2027 to May 21, 2029v45
  9. Site details revised at 1 of 53 sitesv44
  10. 4 versions Re-verified since Feb 3, 2025, no change to tracked fieldsv40-v43
  11. Site details revised at 1 of 53 sitesv39
  12. 3 versions Re-verified since Dec 6, 2024, no change to tracked fieldsv36-v38
  13. Site details revised at 1 of 53 sitesv35
  14. 3 versions Re-verified since Aug 13, 2024, no change to tracked fieldsv32-v34
  15. Study sites revised (53)v31 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (53)v30 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (53)v29 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (53)v28 See this version in full on ClinicalTrials.gov ↗
  19. Re-verified, no change to tracked fieldsv27
  20. Primary completion date: May 1, 2024 to Apr 27, 2027 Completion date: Mar 20, 2026 to Apr 27, 2027 · Study sites revised (53)v26 Show 2 more changesShow less
    • Completion date: Mar 20, 2026 to Apr 27, 2027
    • Study sites revised (53)

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites revised (53)v25 See this version in full on ClinicalTrials.gov ↗
  22. Re-verified, no change to tracked fieldsv24
  23. Study sites revised (53)v23 See this version in full on ClinicalTrials.gov ↗
  24. Re-verified, no change to tracked fieldsv22
  25. Study sites: 50 to 53v21
  26. Completion date: Mar 23, 2026 to Mar 20, 2026v20
  27. Study sites: 46 to 50v19
  28. Study sites: 42 to 46v18
  29. Study sites: 37 to 42v17
  30. Study sites: 34 to 37v16
  31. Study sites: 29 to 34v15
  32. Study sites: 86 to 29v14
  33. Completion date: Aug 1, 2025 to Mar 23, 2026v13
  34. Site details revised at 1 of 86 sitesv12
  35. Study sites revised (86)v11 See this version in full on ClinicalTrials.gov ↗
  36. Study sites revised (86)v10 See this version in full on ClinicalTrials.gov ↗
  • 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.
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts).
Trial Details
NCT Number NCT05379595
Lead Sponsor Janssen Research & Development, LLC
Conditions Advanced or Metastatic Colorectal Cancer
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov