Clinical Trial

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

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 4 changes
critical Enrollment closed, study ongoing 2026-07-31
notable Enrollment increased: 200 -> 220 participants 2026-07-31
notable Primary completion moved earlier: 2027-02-26 -> 2026-10-23 2026-04-24
minor Completion moved earlier: 2027-02-26 -> 2026-10-23 2026-04-24
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 2022-08-04
Primary Completion 2026-10-23 (estimated)
Study Completion 2026-10-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-30