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) (Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors)

Merck Biopharma Co., Ltd.0 个研究点目标入组 45 人开始时间: 2022年9月16日最近更新: 2025年5月19日

适应症

试验速览

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•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

•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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