Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors

Last updated: May 21, 2026
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Not Recruiting

Phase

1

Condition

Cancer

Solid Tumors

Colorectal Cancer

Treatment

M9140

Clinical Study ID

NCT06806046
MS202329_0003
CTR20244167
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and early clinical activity of M9140 in Chinese participants with locally advanced or metastatic colorectal cancer (CRC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with documented histopathological diagnosis of locally advanced ormetastatic CRC, who were intolerant/refractory to or progressed after standardsystemic therapies for the advanced/metastatic stage that included and arerestricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin),an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGFagent. Participants may have received previous treatment with trifluridine/tipiraciland/or regorafenib or fruquintinib, if locally indicated and available. Participantswith a known MSI-H status must have received treatment with an immune checkpointinhibitor (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

  • Cerebrovascular accident/stroke (< 6 months prior to enrollment)

  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: M9140
Phase: 1
Study Start date:
December 20, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670,
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou 1809858,
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926,
    China

    Site Not Available

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