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A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

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Trial Profile

A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Mar 2025

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At a glance

  • Drugs Bevacizumab (Primary) ; Capecitabine (Primary) ; Precemtabart tocentecan (Primary)
  • Indications Colorectal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms PROCEADE-CRC-01
  • Sponsors EMD Serono Research & Development Institute

Most Recent Events

  • 26 Jul 2024 Planned number of patients changed from 180 to 200.
  • 04 Jun 2024 Results (At data cutoff (19 Jan 2024), n=40) assessing safety and efficacy of M9140 in patients (pts) with metastatic colorectal cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 03 Jun 2024 According to a Merck & Co media release, following the completion of the ongoing dose-optimization part, the company plans to assess combinations in colorectal cancer with standard-of-care agents with alternative scheduling options.

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