A Phase II Study of Zolbetuximab, Trastuzumab, and CapeOX, with Pembrolizumab Based on PD-L1 Expression, in Patients with HER2-positive and CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Cancer (ZAP-HETERO study)

未提供0 个研究点目标入组 25 人开始时间: 待定

适应症

试验速览

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•Subjects aged 18 years or older at the time of signing the informed consent form.
•Subjects with histologically confirmed unresectable advanced or recurrent HER2-positive and CLDN18.2-positive gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, corresponding to malignant epithelial tumors, common type, according to the 15th edition of the Japanese Classification of Gastric Carcinoma.
•Subjects with no prior systemic therapy for gastric cancer or gastroesophageal junction cancer. However, subjects who received adjuvant chemotherapy are eligible if at least 180 days have elapsed since the last dose.
•Availability for submission of unstained thin-section specimens, consisting of six 4-um-thick sections, prepared from the formalin-fixed paraffin-embedded (FFPE) specimen used for HER2 diagnosis.
•Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
•Presence of at least one measurable lesion according to RECIST version 1.1 on CT or MRI performed within 28 days before registration.

•Subjects with known dihydropyrimidine dehydrogenase (DPD) deficiency.
•Subjects with a history of severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, or CapeOX.
•Subjects with active bleeding from gastric cancer, gastroesophageal junction cancer, or peptic ulcer.
•Subjects with active multiple primary cancers with a disease-free interval of less than 5 years. However, subjects with lesions confined to intramucosal carcinoma are eligible.
•Subjects with any of the following cardiac diseases or conditions within 6 months before registration:
•a. Congestive heart failure of New York Heart Association (NYHA) functional class III or higher;
•b. Uncontrolled and high-risk arrhythmia;
•c. History of acute coronary syndrome within 6 months;
•d. Uncontrolled hypertension, defined as systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg;
•e. Left ventricular ejection fraction (LVEF) <50% on echocardiography (ECHO).
•Subjects with serious comorbidities, such as interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, or uncontrolled diabetes mellitus, or subjects with a history of interstitial pneumonia or pulmonary fibrosis.

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