PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol) (Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors(PROCEADE PanTumor))

Merck Biopharma Co., Ltd.0 个研究点目标入组 250 人开始时间: 2025年4月15日最近更新: 2025年5月30日

试验速览

暂无简介。

•Participants are capable of signing informed consent as defined in protocol
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal t1
•Participants with adequate hematologic, hepatic and renal function as defined in protocol
•Participant must have at least 1 lesion that is measurable using RECIST v1.
•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
•Cardiac arrhythmia, 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

Objective Response (OR)

According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators

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发起方