A study of zolbetuximab (IMAB362) in adults with gastric cancer

Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer). 患有这种癌症的大多数受试者的肿瘤中都含有一种名为 Claudin 18.2 的蛋白质。Zolbetuximab is thought to work by attaching to Claudin 18.2 in their tumor. 这将启动人体的免疫系统来攻击肿瘤。There is an unmet medical need to treat people with advanced cancer in and around the stomach or gastroesophageal junction cancer. This study will provide more information on zolbetuximab given by itself and in combination with other treatments in adults with advanced stomach or gastroesophageal junction cancer. 这项研究目前正在全球范围内进行。People in this study will either be treated with zolbetuximab by itself, with zolbetuximab and chemotherapy, with zolbetuximab and a medicine called pembrolizumab, or zolbetuximab with chemotherapy and a medicine called nivolumab.

This study is ongoing, but enrollment in any of the treatment options has been completed. In addition, at this stage of the study, treatment in some of these treatment options has completed.

The main aim of this study is to check how well zolbetuximab controls tumors when given by itself.

Adults with cancer in and around the stomach or gastroesophageal junction cancer can take part. Their cancer is locally advanced unresectable or metastatic and has the CLDN18.2 marker in a tumor sample. 局部晚期是指癌症已扩散到附近的组织。不可切除是指癌症无法通过手术切除。转移意味着癌症已扩散到身体其他部位。They may have been previously treated with standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, have a specific heart condition or infections.

There are different treatments in the study. People who take part will receive just 1 of the treatments.

Treatment will be given in cycles. The treatment is given through a vein; this is called an infusion. Some people with advanced disease will have 1 infusion in 3 week (21-day) cycles. Some people will have several infusions in 6 week (42-day) cycles. Some people with cancer in and around the stomach or gastroesophageal junction who have surgery for their cancer will have a few infusions in 2-week (14-day) cycles. This will happen before and after they have surgery for their cancer.

People may receive chemotherapy for up to 6 months. Some people enrolled to received zolbetuximab and pembrolizumab, may have received pembrolizumab for up to 2 years.

People will visit the clinic on certain days during their treatment; there may be extra visits during the first cycle of treatment. The study doctors will check if people had any medical problems from zolbetuximab and the other study treatments. 此外，参与研究的受试者还将接受包括血液化验在内的健康检查。在一些就诊中，他们还将接受扫描，以检查癌症是否有任何变化。Tumor samples will be taken at certain visits with the option of giving a tumor sample after treatment has finished.

受试者将在停止治疗后到诊所进行访视。他们将被问及任何医疗问题，并接受包括血液化验在内的健康检查。After the clinic visits end some people will have a telephone health check every 3 months. 访视次数和每次访视时进行的检查将取决于每名受试者的健康状况以及他们是否已完成治疗。