ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is
available as a treatment, the researchers need to understand how it is processed by and acts
upon the body. This information will help find a suitable dose and check for potential
medical problems from the treatment. People in this study will be adults with metastatic or
locally advanced solid tumors. Metastatic means the cancer has spread to other parts of the
body. They will have been previously treated with all available standard therapies and they
may no longer be benefitting from further treatment.
There are 2 main aims of this study. The first is to learn if people with certain solid
tumors have any medical problems after receiving different doses of ASP2074. The second is to
find a suitable dose of ASP2074 to use in future studies.
This study will be in 2 parts.
In Part 1, different small groups of people will receive lower or higher doses of ASP2074.
Any medical problems will be recorded at each dose. This is done to find suitable doses of
ASP2074 to use in Part 2 of the study. The first group will receive the lowest dose of
ASP2074. A medical expert panel will check the results from this group and decide if the next
group can receive a higher dose of ASP2074. The panel will do this for each group until all
groups have taken ASP2074 or until suitable doses have been selected for Part 2.
In Part 2, other different small groups of people will receive ASP2074 with the most suitable
doses worked out from Part 1. This will help find a more accurate dose of ASP2074 to use in
future studies.
ASP2074 will be given as an infusion on the first day of each treatment cycle. The people in
this study will have treatment cycles until: they have medical problems from the treatment;
their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or
they do not come back for treatment.
People will visit the clinic on certain days during their treatment, with extra visits during
the first 2 cycles of treatment. During these visits, the study doctors will check for any
medical problems from ASP2074. At some visits, other checks will include a medical
examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and
blood pressure. Also, blood and urine samples will be taken. Electrocardiograms will be done
to check the heart rhythm during the study. Tumor samples will be taken during certain visits
before treatment begins, during treatment, and when treatment has finished.
People will visit the clinic within 7 days after stopping treatment. The study doctors will
check for any medical problems from ASP2074. Other checks will include a medical examination,
laboratory tests and vital signs. Then, people may visit the clinic at 30 days after stopping
treatment. Thirty and 90 days after the last dose, the study doctors will check for any
medical problems from ASP2074. People will have their vital signs checked and have some
laboratory tests. After this, people will continue to visit the clinic every 6 weeks. This is
to check the condition of their cancer. They will do this until their cancer is worse, they
start other cancer treatment, they ask to leave the study, or they do not come back for
treatment. Then, the study doctors will call every 12 weeks for up to 1 year or until that
person asks to leave the study, the study is stopped, or the person cannot be reached.