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New hope for advanced colorectal cancer: first human trial launches

NCT ID NCT05464030

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a new drug called M9140 in people with advanced colorectal cancer that has not responded to standard treatments. The drug works by targeting a protein on cancer cells to deliver a chemotherapy-like agent directly to the tumor. The trial has two parts: first finding a safe dose, then testing how well it works in a larger group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

220 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Japan

  • Asan Medical Center

    Seoul, South Korea

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92024, United States

  • California Cancer Associates for Research & Excellence, Inc.

    Fresno, California, 93720, United States

  • Cancer Institute Hospital of JFCR

    Kōtoku, Japan

  • Centro Integral Oncologico Clara Campal

    Madrid, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital HM Nou Delfos

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron - VHIR

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Quironsalud Madrid - NEXT Oncology

    Madrid, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital del Mar

    Barcelona, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Spain

  • Kanagawa Cancer Center

    Yokohama, Japan

  • Kindai University Hospital

    Osakasayama-shi, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • MD Anderson Cancer Center - Oncology

    Houston, Texas, 77030, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • National Cancer Center

    Goyang-si, South Korea

  • National Cancer Center Hospital - Dept of Gastroenterology

    Chūōku, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Japan

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Saitama Cancer Center

    Kitaadachi-gun, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shizuoka Cancer Center

    Sunto-gun, Japan

  • The Ottawa Hospital Cancer Centre

    Ottawa, Canada

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.