ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers.
ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells
alone. It also makes the cancer cells visible to the immune system which will fight the
cancer cells.
Before ASP1012 is available as a treatment, the researchers need to understand how it is
processed by and acts upon the body. This will help find a suitable dose for future studies
and check for potential medical problems from the treatment.
In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been
tested in the laboratory and in animals. This is the standard way new potential treatments
are developed.
People in this study will be adults whose tumor has either grown outside of the area where it
started (locally advanced) or it has spread to other parts of the body (metastatic). They
will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved
medicine.
There are 2 main aims of this study. The first is to learn if people with certain solid
tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of
ASP1012.
This study will be in 3 parts.
Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take
part. They will have been previously treated with all available standard cancer therapies.
Different small groups of people will receive lower to higher doses of ASP1012.
For each dose, any medical problems will be recorded. This will help to find suitable doses
of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose
of ASP1012. A medical expert panel will check the results from this group and decide if the
next group can receive a higher dose of ASP1012. The panel will do this for each group until
all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3.
Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated
melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or
their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and
people with previously-treated solid tumors. People with previously-treated melanoma will
receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid
tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at
a lower dose than the dose worked out from Part 1, to check the safety of the treatments
being given together. If there are no safety issues: the next people in the solid tumor group
will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with
untreated melanoma will receive ASP1012 at the dose worked out from Part
1, with pembrolizumab.
Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach
cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in
Parts 1 and 2 of the study, other people with this same type of tumor can also take part in
Part 3.
For all parts of the study, ASP1012 will be given through a vein. This is called an infusion.
Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in
the study may receive extra treatment cycles, if they respond well to treatment. People with
melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment
cycles. People can stop leave the study early if: they have medical problems from the
treatment; their cancer gets worse; they start other cancer treatment; they ask to stop
treatment; or they do not come back for treatment.
People will visit the clinic on certain days during their treatment. Some visits will be
virtual or by phone. During all clinic visits, the study doctors will check for any medical
problems from ASP1012. They will also check vital signs. Vital signs include temperature,
pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits,
other checks will also include a medical examination, and an electrocardiogram (ECG) to check
the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available,
will be taken during the first treatment cycle. People will have imaging scans and have blood
draws for testing every 6 weeks during and after treatment. This will stop if they leave the
study early.
People will visit the clinic within 7 days and 30 days after stopping treatment. At both
visits, the study doctors will check for any medical problems from ASP1012. Other checks will
include a medical examination, blood draws and urine samples for testing and checking vital
signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will
phone people in the study every 12 weeks to check the condition of their cancer for up to 1
year.