Phase
Condition
Cancer
Solid Tumors
Colorectal Cancer
Treatment
M9140
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670,
ChinaSite Not Available
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou 1809858,
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou 1808926,
ChinaSite Not Available

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