A Study of ASP1570 in Adults With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2023-10-31
Target enrollment:
Participant gender:
Summary
This study is for adults with advanced solid tumors. Their tumor has either grown outside of
the area where it started or it has spread to other parts of the body. Their cancer gets
worse after standard therapy or they are unable to have standard therapy.
This study will provide more information on a potential new treatment for people with
advanced solid tumors, called ASP1570.
This study will be in 2 parts.
In Part 1, the best dose of ASP1570 to give to people with advanced solid tumors will be
worked out. Different small groups of people with advanced solid tumors will take lower to
higher doses of ASP1570. There are 8 different doses in total, with each group staying on the
same dose. After taking the lowest dose, the first group will be checked for medical
problems. The next group can only take the higher dose if the first group on the lowest dose
had no major medical problems. This will continue in the same way for each group. This means
each group will take the next highest dose of ASP1570 as long as the previous group did not
have any major medical problems.
Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle.
They will continue with more treatment cycles on the same dose unless they have major medical
problems, their cancer gets worse or the study doctor decides that person should stop
treatment.
In Part 2, different small groups of people with advanced solid tumors will take the best
dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that
people took in Part 1 without getting major medical problems. Some groups of people will have
specific advanced tumors. These include tumors from metastatic melanoma or non-small cell
lung cancer (NSCLC for short). Other groups will have solid tumors that showed a response in
Part 1. Again, each group will take tablets of ASP1570 once every day in a 21-day cycle. They
will continue with more treatment cycles unless they have major medical problems, their
cancer gets worse or the study doctor decides that person should stop treatment.
After treatment, people in the study will visit their clinic 45 days after their last dose of
ASP1570. Then, the study clinic will contact each person in the study at least every 12 weeks
until the end of the study or if they decide to leave the study.