A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

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  1. Phase changed: Phase 3 → Phase 2
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Study sites revised (51)
  2. Primary and study completion dates: Oct 2028 to Aug 2027v42 Show 8 more changesShow less
    • Primary endpoints revised (6)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 460 to confirmed 74
    • Interventions: Bevacizumab (Drug), Telisotuzumab Adizutecan (Drug), Trifluridine/Tipiracil (Drug) to Telisotuzumab Adizutecan (Drug)
    • Secondary endpoints: 21 to 15
    • Study sites revised (51)
    • Study title shortened, about 11 words
    • Study arms: 4 to 2
  3. Study sites revised (51)v41
  4. Study sites: 50 to 51v40 Show 5 more changesShow less
    • Primary and study completion dates: Apr 2029 to Oct 2028
    • Interventions: ABBV-400 (Drug), Bevacizumab (Drug), Trifluridine/Tipiracil (Drug) to Bevacizumab (Drug), Telisotuzumab Adizutecan (Drug), Trifluridine/Tipiracil (Drug)
    • Secondary endpoints revised (21)
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 3 words
  5. Study sites: 49 to 50v39
Show 37 earlier versionsHide 37 earlier versions
  1. Re-verified, no change to tracked fieldsv38
  2. Study sites: 48 to 49v37
  3. Study sites: 47 to 48v36
  4. Study sites: 46 to 47v35
  5. Study sites: 44 to 46v34
  6. Study sites: 43 to 44v33
  7. Study sites: 42 to 43v32
  8. Study sites: 41 to 42v31
  9. Study sites: 40 to 41v30
  10. Study sites: 39 to 40v29
  11. Study sites: 37 to 39v28
  12. Study sites: 35 to 37v27
  13. Study sites: 33 to 35v26
  14. Study sites: 31 to 33v25
  15. Study sites: 30 to 31v24
  16. Study sites: 28 to 30v23
  17. Study sites: 27 to 28v22
  18. Study sites: 26 to 27v21
  19. Study sites: 25 to 26v20
  20. Study sites: 23 to 25v19
  21. Study sites: 22 to 23v18
  22. Study sites: 21 to 22v17
  23. Study sites: 19 to 21v16
  24. Study sites: 18 to 19v15
  25. Site details revised at 1 of 18 sitesv14
  26. Study sites: 17 to 18v13
  27. Study sites: 16 to 17v12
  28. Study sites: 15 to 16v11
  29. Study sites: 13 to 15v10
  30. Study sites: 11 to 13v9
  31. Study sites: 10 to 11v8
  32. Study sites: 9 to 10v7
  33. Study sites: 6 to 9v6
  34. Study sites: 4 to 6
    • Primary and study completion dates: Apr 6, 2029 to Apr 2029
    v5
  35. Study sites: 2 to 4v4
  36. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Nov 24, 2024 to Nov 8, 2024
    v3
  37. Study title shortened, about 5 wordsv2
  1. 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.
AbbVie
349 trials monitored
See 27 trials at risk
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries. Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial Details
NCT Number NCT06614192
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Metastatic Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov