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Evaluating M9140 for advanced colorectal cancer

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)

Phase 1 Interventional EMD Serono · NCT05464030

This study is testing a new drug called M9140 to see if it can help people with advanced colorectal cancer who haven't had success with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorEMD Serono Industry-sponsored
Locations35 sites (Encinitas, California and 34 other locations)
Trial IDNCT05464030 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in patients with advanced solid tumors, specifically colorectal cancer. The study is divided into two parts: a dose escalation phase to determine the optimal dosage and a dose expansion phase to further evaluate the drug's effectiveness. Participants will receive M9140 along with other treatments such as Bevacizumab and Capecitabine. The trial is designed for individuals who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are individuals with locally advanced or metastatic colorectal cancer who have not responded to standard systemic therapies.

Not a fit: Patients with a history of malignancy within the last three years, except for certain skin cancers, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: Other studies involving similar approaches have shown promise, but this specific treatment is being evaluated for the first time in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. 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.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
* Participants with adequate hematologic, hepatic and renal function as defined in protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Participants with diarrhea (liquid stool) or ileus Grade \> 1
* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] \>= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \> 470 milliseconds (ms)
* Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
* Other protocol defined exclusion criteria could apply

Where this trial is running

Encinitas, California and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.