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OncoMatch/Clinical Trials/NCT05464030

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

Is NCT05464030 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for colorectal cancer.

Phase 1RecruitingEMD Serono Research & Development Institute, Inc.NCT05464030Data as of May 2026

Treatment: M9140 · M9140 · Bevacizumab · Capecitabine · 5-fluorouracil (5-FU) · Folinic acid — 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

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard systemic therapies — advanced/metastatic

intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant

Must have received: immune checkpoint inhibitor

Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated

Lab requirements

Blood counts

adequate hematologic function as defined in protocol

Kidney function

adequate renal function as defined in protocol

Liver function

adequate hepatic function as defined in protocol

Participants with adequate hematologic, hepatic and renal function as defined in protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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