A study of ASP3082 in adults with advanced solid tumors

What to expect

This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. This study will be in 2 parts.

In Part 1, different small groups of people will receive lower to higher doses of either: ASP3082 by itself or ASP3082 together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.

In Part 2, other different small groups of people will receive: ASP3082 by itself, ASP3082 with cetuximab, ASP3082 with different types of chemotherapy, ASP3082 with pembrolizumab, or ASP3082 with chemotherapy and pembrolizumab. The most suitable doses of ASP3082 worked out from Part 1 will be used.

Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. People will continue treatment until:

• they have medical problems from the treatment they can’t tolerate;
• their cancer gets worse;
• they start other cancer treatment;
• or they ask to stop treatment.

People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. At the clinic visits people will have health checks. Tumor samples will be taken at certain visits during treatment and when treatment has finished.

People will visit the clinic shortly after stopping treatment for a health check. After this, people will continue to have health checks every couple of months to check the condition of their cancer. They will do this until about 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer treatment, or they ask to stop treatment.