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Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Enrollment increased: 200 → 220 participants · Site details revised at 35 of 35 sitesv36 Show 2 more changesShow less
    • Enrollment increased: 200 → 220 participants
    • Site details revised at 35 of 35 sites
  2. 2 versions Re-verified since May 21, 2026, no change to tracked fieldsv34-v35
  3. Primary and study completion moved earlier from Feb 26, 2027 to Oct 23, 2026v33
  4. Re-verified, no change to tracked fieldsv32
  5. Primary and study completion dates: Aug 7, 2026 to Feb 26, 2027v31
Show 29 earlier versionsHide 29 earlier versions
  1. 2 versions Re-verified since Sep 21, 2025, no change to tracked fieldsv29-v30
  2. Publications: details revised at 1 of 2 entriesv28
  3. Primary and study completion dates: Feb 27, 2026 to Aug 7, 2026 Site details revised at 2 of 35 sitesv27 Show 1 more changeShow less
    • Site details revised at 2 of 35 sites
  4. 2 versions Re-verified since Apr 14, 2025, no change to tracked fieldsv25-v26
  5. Site details revised at 1 of 35 sitesv24
  6. 2 versions Re-verified since Jan 10, 2025, no change to tracked fieldsv22-v23
  7. Study sites revised (35)v21 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 30 to 35v20
  9. Study sites: 24 to 30v19
  10. Study sites: 17 to 24v18
  11. Primary endpoints revised (6) Enrollment target: 180 to 200 · Study sites: 6 to 17 · Interventions: Bevacizumab (Drug), Capecitabine (Drug), M9140 (Drug), M9140 (Drug) to 5-fluorouracil (5-FU) (Drug), Bevacizumab (Drug), Capecitabine (Drug), Folinic acid (Drug), M9140 (Drug), M9140 (Drug) · 2 morev17 Show 5 more changesShow less
    • Enrollment target: 180 to 200
    • Study sites: 6 to 17
    • Interventions: Bevacizumab (Drug), Capecitabine (Drug), M9140 (Drug), M9140 (Drug) to 5-fluorouracil (5-FU) (Drug), Bevacizumab (Drug), Capecitabine (Drug), Folinic acid (Drug), M9140 (Drug), M9140 (Drug)
    • Secondary endpoints: 11 to 12
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 5 to 6v16
  13. Study title expanded, about 1 wordv15 See this version in full on ClinicalTrials.gov ↗
  14. Re-verified, no change to tracked fieldsv14
  15. Eligibility criteria expanded, about 1 wordv13 See this version in full on ClinicalTrials.gov ↗
  16. Primary completion date: Apr 24, 2024 to Feb 27, 2026 Completion date: May 1, 2025 to Feb 27, 2026v12 Show 1 more changeShow less
    • Completion date: May 1, 2025 to Feb 27, 2026
  17. Enrollment target: 31 to 180 Primary endpoints: 2 to 6 · Primary completion date: Nov 28, 2023 to Apr 24, 2024 · Completion date: Nov 28, 2023 to May 1, 2025 · 3 morev11 Show 6 more changesShow less
    • Primary endpoints: 2 to 6
    • Primary completion date: Nov 28, 2023 to Apr 24, 2024
    • Completion date: Nov 28, 2023 to May 1, 2025
    • Interventions: M9140 (Drug) to Bevacizumab (Drug), Capecitabine (Drug), M9140 (Drug), M9140 (Drug)
    • Secondary endpoints: 8 to 11
    • Study arms: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  18. 3 versions Re-verified since Aug 14, 2023, no change to tracked fieldsv8-v10
  19. Enrollment target: 30 to 31v7
  20. Re-verified, no change to tracked fieldsv6
  21. Site details revised at 2 of 5 sitesv5
  22. Re-verified, no change to tracked fieldsv4
  23. Site details revised at 2 of 5 sitesv3
  24. Start date changed from estimate of Jul 15, 2022 to Aug 4, 2022v2
  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
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program
Trial Details
NCT Number NCT05464030
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Colorectal Cancer
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov