Estudio de ASP3082 en adultos con tumores sólidos avanzados

What to expect

Este es un estudio abierto. Esto significa que las personas que participen en este estudio y el personal de la clínica sabrán que recibirán ASP3082. Este estudio se realizará en 2 partes.

In Part 1, different small groups of people will receive lower to higher doses of either: ASP3082 by itself or ASP3082 together with cetuximab. Cualquier problema médico se registrará en cada dosis. This is done to find suitable doses of ASP3082, by itself or together with cetuximab to use in Part 2 of the study. El primer grupo recibirá la dosis más baja de ASP3082. Un panel de expertos médicos verificará los resultados de este grupo y decidirá si el siguiente grupo puede recibir una dosis más alta de ASP3082. El panel hará esto para cada grupo hasta que todos los grupos hayan recibido ASP3082 (solo o junto con cetuximab) o hasta que se hayan seleccionado las dosis adecuadas para la Parte 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.

Los tratamientos del estudio se administrarán a través de una vena. Este procedimiento se llama “infusión”. Cada ciclo de tratamiento dura 21 o 28 días. 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.