Summary
Genes contain genetic code which tell the body which proteins to make. Many types of
cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are
looking for ways to stop the actions of abnormal proteins made from the mutated KRAS
gene.
ASP5834 is being studied in people with solid tumors who have certain KRAS gene
mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will
be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In
this study, the researchers will learn how ASP5834 is processed by and acts upon the
body. This information will help find a suitable dose of ASP5834 and check for any
potential medical problems from the treatment.
The main aims of this study are to check the safety of ASP5834 given by itself or given
with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834
given by itself or given with panitumumab.
People in this study will be adults with locally advanced, unresectable, or metastatic
solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has
spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery.
Metastatic means the cancer has spread to other parts of the body. The key reasons people
cannot take part are if they have specific uncontrollable cancers such as symptomatic or
untreated cancers in nervous system, or have a specific heart condition, or infections.
In this study, ASP5834 is being given to humans for the first time. This is an open-label
study. This means that people in this study and clinic staff will know that they will
receive ASP5834 by itself or ASP5834 with panitumumab.
This study will be in 2 parts:
Part 1 is called Dose Escalation. Different small groups of people will receive lower to
higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. Only people who
have colorectal cancer will receive ASP5834 with panitumumab. People with any type of
solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be
recorded. A medical expert panel will check the results and decide if the next group can
receive a higher dose of ASP5834. The panel will do this until the planned maximum number
of people are treated or until suitable doses have been selected for Part 2.
Part 2 is called Dose Expansion. Other different small groups of people will receive
ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out
from Part 1.
In both parts of the study, the study treatments ASP5834 and panitumumab will be given
through a vein. This is called an infusion. Each study treatment cycle is either 21 days
or 28 days long. People will continue study treatment until: they have medical problems
from the study treatment they can't tolerate; their cancer gets worse; they start other
cancer treatment; or they ask to stop study treatment.
People will visit the clinic on certain days during their study treatment, with extra
visits during the first 2 cycles of study treatment. The study doctors will check for any
medical problems from ASP5834. Also, people in the study will have a health check. On
some visits they will also have scans to check for any changes in their cancer. Tumor
samples will be taken at certain visits during study treatment with the option of a tumor
sample being taken if people's cancer gets worse or the cancer comes back.
People will visit the clinic shortly after stopping treatment for a health check. After
this, people will have health checks every couple of months to check the condition of
their cancer. The number of visits and checks done will depend on the health of each
person and whether they completed their study treatment or not. It is expected that
people will be in this study for about 1 year.