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Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 26% 250 → 184 participants
See other at-risk trials from Merck KGaA

Record History

  1. Enrollment reduced: 250 → 184 participantsv17
  2. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 81 of 81 sitesv16 Show 1 more changeShow less
    • Site details revised at 81 of 81 sites
  3. Study sites: 82 to 81v15
  4. Re-verified, no change to tracked fieldsv14
  5. Study sites: 81 to 82v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 61 to 81v12
  2. Study sites: 54 to 61 Primary and study completion dates: Jan 26, 2028 to Dec 23, 2027v11 Show 1 more changeShow less
    • Primary and study completion dates: Jan 26, 2028 to Dec 23, 2027
  3. Study sites: 49 to 54v10
  4. Study sites: 38 to 49v9
  5. Study sites: 37 to 38v8
  6. Study sites: 31 to 37v7
  7. Primary and study completion dates: Jan 31, 2029 to Jan 26, 2028 Study sites: 4 to 31v6 Show 1 more changeShow less
    • Study sites: 4 to 31
  8. 2 versions Re-verified since Apr 15, 2025, no change to tracked fieldsv4-v5
  9. Study sites: 1 to 4v3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 1 · Start date changed from estimate of Feb 15, 2025 to Jan 29, 2025v2 Show 2 more changesShow less
    • Study sites: 2 to 1
    • Start date changed from estimate of Feb 15, 2025 to Jan 29, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Pancreatic Cancer
1,639 trials monitored
See 91 trials at risk
and 1 more disease
The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel. * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).
Trial Details
NCT Number NCT06710132
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany
Conditions Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov