A Study of ASP1893 in Adults With Advanced CLDN6-positive Solid Tumors
brief summary
Before a treatment can be approved for use, clinical studies need to be done. This study is for people with certain types of cancer that have become worse and are difficult to treat. The types of cancer include testicular, ovarian, non-small cell lung cancer, and cancer of the womb (endometrial cancer). The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced). The cells from these cancers have a protein called Claudin 6 (CLDN6). These cancer cells are known as CLDN6-positive. ASP1893, the study treatment in this study is thought to bind to CLDN6 and a protein found on certain immune cells. This process "tells" the immune system to attack the tumor. The main aims of the study are to check the safety of ASP1893 in people with these types of cancer, to check if the people can tolerate ASP1893, and to find a suitable dose of ASP1893. This study will be in 2 parts. In the first part, different small groups of people with testicular cancer, ovarian cancer, non-small cell lung cancer and endometrial cancer will receive lower to higher doses of ASP1893. This will happen one group after another. People who take part in the second part of this study will receive doses of ASP1893 that worked the best in the first part of the study. Different larger groups of people with ovarian cancer, non-small cell lung cancer, and any of the other types of cancer that responded to ASP1893 in the first part of the study will be able to take part in the second part. In both parts of the study, ASP1893 will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every 2 or 3 weeks. People will continue to receive ASP1893 for up to 1 year, or until their cancer gets worse or they start to have medical problems. People taking part have the option to continue with ASP1893 for another year if the study doctor decides the study treatment is still working well. People in the study can also choose to stop taking part at any time, without giving a reason. During the study, people will visit their study clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every 8 or 9 weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by body scans (CT or MRI scans). People will also have their nervous system checked. This includes checking their mental status, reflexes, balance, and coordination. They will also have an eye exam. A tumor sample will be taken during the study and people will have the option of giving a tumor sample after treatment has finished. If people stop the study treatment, they will have follow-up safety checks for up to 1 year after their last dose of ASP1893.
official title
A Phase 1 Study of ASP1893 in Participants With Metastatic or Locally Advanced CLDN6-positive Solid Tumors