Clinical Trial

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

Active, Not Recruiting Phase 1/2
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Summary
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).
Protocol Amendment History 2 changes
notable Enrollment reduced: 250 -> 184 participants 2026-07-31
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-29
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 2025-01-29
Primary Completion 2027-12-23 (estimated)
Study Completion 2027-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-30