A study of zolbetuximab with chemotherapy in adults with pancreatic cancer

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.

In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.

Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.

There are 2 main aims of this study:

-To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer

-To check if people could cope with (tolerate) any medical problems during the study

本研究为开放性研究。This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.

Zolbetuximab and chemotherapy will be given through a vein. 这一过程称为输液。People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.

People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. 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。People will visit the study clinic about 7 days after they stop treatment. 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 this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.