🏛️ Verified NIH Record • Updated 2026-07-29

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (NCT05464030)

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)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: EMD Serono Research & Development Institute, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: California Cancer Associates for Research & Excellence, Inc. — Encinitas, California

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (35 Sites)

Showing the first 25 of 35 sites.

  • California Cancer Associates for Research & Excellence, Inc. — Encinitas, California
  • California Cancer Associates for Research & Excellence, Inc. — Fresno, California
  • Rhode Island Hospital — Providence, Rhode Island
  • Mary Crowley Cancer Research — Dallas, Texas
  • MD Anderson Cancer Center - Oncology — Houston, Texas
  • NEXT Oncology — San Antonio, Texas
  • The Ottawa Hospital Cancer Centre — Ottawa,
  • University Health Network - Princess Margaret Cancer Centre — Toronto,
  • National Cancer Center Hospital - Dept of Gastroenterology — Chūōku,
  • National Cancer Center Hospital East — Kashiwa-shi,
  • Saitama Cancer Center — Kitaadachi-gun,
  • Cancer Institute Hospital of JFCR — Kōtoku,
  • Aichi Cancer Center Hospital — Nagoya,
  • Kindai University Hospital — Osakasayama-shi,
  • Shizuoka Cancer Center — Sunto-gun,
  • Kanagawa Cancer Center — Yokohama,
  • Kyungpook National University Chilgok Hospital — Daegu,
  • National Cancer Center — Goyang-si,
  • Seoul National University Bundang Hospital — Seongnam,
  • Asan Medical Center — Seoul,
  • Samsung Medical Center — Seoul,
  • Seoul National University Hospital — Seoul,
  • Severance Hospital, Yonsei University Health System — Seoul,
  • Hospital Clinic de Barcelona — Barcelona,
  • Hospital del Mar — Barcelona,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗