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

Last updated: May 5, 2025
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Colon Cancer

Colon Cancer; Rectal Cancer

Colorectal Cancer

Treatment

M9140

Folinic acid

Capecitabine

Clinical Study ID

NCT05464030
MS202329_0001
2022-500508-23-00
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with documented histopathological diagnosis of locally advanced ormetastatic colorectal cancer (CRC), who were intolerant/refractory to or progressedafter standard systemic therapies for the advanced/metastatic stage, if locallyindicated and available to the participant. Participants with a known microsatelliteinstability high (MSI-H) status must have received treatment with an immunecheckpoint 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 inprotocol

  • Other protocol defined inclusion criteria could apply

Exclusion

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 situof the cervix, benign prostate neoplasm/hypertropia, or malignancy that in theopinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, isconsidered cured with minimal risk of recurrence within 3 years)

  • Participants with known brain metastases, except those meeting the followingcriteria: Brain metastases that have been treated locally and are clinically stablefor at least 4 weeks prior to the start of treatment; No ongoing neurologicalsymptoms that are related to the brain localization of the disease (sequelae thatare 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., ulcerativecolitis, Crohn's disease, intestinal perforation) and/or bowel obstruction

  • Unstable angina, myocardial infarction, congestive heart failure (New York HeartAssociation [NYHA] >= II) or a coronary revascularization procedure within 180 daysof 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

Study Design

Total Participants: 200
Treatment Group(s): 5
Primary Treatment: M9140
Phase: 1
Study Start date:
August 04, 2022
Estimated Completion Date:
February 27, 2026

Connect with a study center

  • The Ottawa Hospital Cancer Centre

    Ottawa,
    Canada

    Active - Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto,
    Canada

    Active - Recruiting

  • National Cancer Center Hospital - Dept of Gastroenterology

    Chuo-ku,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi,
    Japan

    Active - Recruiting

  • Saitama Cancer Center

    Kitaadachi-gun,
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-ku,
    Japan

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya-shi,
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi,
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Sunto-gun,
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama-shi,
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital HM Nou Delfos

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron - VHIR

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba,
    Spain

    Active - Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat,
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid - NEXT Oncology

    Madrid,
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California 92024
    United States

    Active - Recruiting

  • California Cancer Associates for Research & Excellence, Inc.

    Fresno, California 93720
    United States

    Active - Recruiting

  • Piedmont Cancer Institute

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • MD Anderson Cancer Center - Oncology

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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