A Study of ASP1002 in Adults for Treatment of Solid Tumors
Status:
Not yet recruiting
Trial end date:
2028-05-31
Target enrollment:
Participant gender:
Summary
ASP1002 is a potential new treatment for people with certain solid tumors. Before ASP1002 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 locally advanced or metastatic solid tumors with
high levels of a protein called claudin 4. Metastatic means the cancer has spread to other
parts of the body. They will have been previously treated with available standard therapies
or refused to receive those treatments.
There are 2 main aims of this study. One is to learn if people with certain solid tumors have
any medical problems or side effects after receiving different doses of ASP1002. The other is
to find a suitable dose of ASP1002 to use in future studies.
This study will be in 2 parts.
In Part 1, different small groups of people will receive lower to higher doses of ASP1002.
Any medical problems and side effects will be recorded at each dose. This is done to find
suitable doses of ASP1002 to use in Part 2 of the study. The first group will receive the
lowest dose of ASP1002. A medical expert panel will check the results from this group and
decide if the next group can receive a higher dose of ASP1002. The panel will do this for
each dose group until all groups have taken ASP1002 or until suitable doses have been
selected for Part 2.
In Part 2, other different small groups of people will receive ASP1002 with the most suitable
doses determined from Part 1. This will help find a more accurate dose of ASP1002 to use in
future studies.
During both parts of the study, ASP1002 will be given through a vein. This is called an
infusion. Each treatment cycle is 21 days long and the infusion is given weekly. People in
this study will continue treatment for up to 2 years (32 cycles) until: they have medical
problems or side effects that prevent them from continuing treatment; their cancer gets
worse; they start other cancer treatment; they ask to stop treatment; they do not come back
for treatment.
People will visit the clinic several times during each treatment cycle. They will receive
ASP1002 infusions 3 times during each treatment cycle. Each infusion could take 15 minutes to
2 hours, depending on the dose. In addition to infusions, other checks will occur during the
visit. During these visits, the study doctors will check for any medical problems and side
effects from ASP1002. At some visits, other checks will include a medical examination,
laboratory tests and vital signs. Vital signs include temperature, pulse, breathing rate,
oxygen saturation, and blood pressure. Also, blood and urine samples will be taken. Tumor
samples will be taken during certain visits 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 and side effects from ASP1002. Other checks will include a
medical examination, laboratory tests and vital signs. Then, they may visit the clinic at 30
days (1 month) and 90 days (3 months) after stopping treatment. At the 30-day visit, the
study doctors will check for any medical problems and side effects from ASP1002. People will
have their vital signs checked and have some laboratory tests. At the 90-day visit, the study
doctors will check for any medical problems and side effects from ASP1002 and people will
have their vital signs checked. After this, people will continue to visit the clinic every 9
to 12 weeks. This is to check the condition of their cancer.