A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer
Status:
Not yet recruiting
Trial end date:
2026-01-31
Target enrollment:
Participant gender:
Summary
ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal
junction cancer, or pancreatic cancer. Before ASP2138 is available as a treatment, the
researchers need to understand how it is processed by and acts upon the body. They do this to
find a suitable dose and to check for potential medical problems from the treatment.
People who are 18 years or older can take part. This is an open-label study. This means that
people in this study will know that they will receive ASP2138.
The study will have 2 phases. Phase 1 is called dose escalation. Different small groups of
people will take lower to higher doses of ASP2138. Medical problems will be recorded at each
dose. This is done to find suitable doses of ASP2138 to use later in the study. Doctors will
also check how each type of cancer is responding to ASP2138.
Phase 1b is called dose expansion. Other different small groups will take part, and will take
suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer
responds to ASP2138. The response to ASP2138 is measured using x-rays, scans and blood tests.
Doctors will continue to check all medical problems throughout the study.
ASP2138 will be given through a vein in the arm. This is called an infusion. People will
continue to receive treatment until: their disease gets worse; they have medical problems
they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment
is no longer in that person's best interest; the study is ended by the sponsor. Study doctors
will check for any medical problems from ASP2138. Other checks will include physical exams,
checking the nervous system, laboratory tests and vital signs. Nervous system checks include
checking reflexes, balance, movement and muscle strength. Vital signs include body
temperature, blood pressure and pulse. Electrocardiograms (ECG) will be done to check the
heart rhythm during the study. People will receive ASP2138 in a hospital. They will give
blood samples and study doctors will check for medical problems. People will also visit the
clinic on certain days during their treatment, with extra visits during the first 3 cycles of
treatment.
People will visit the clinic after treatment has finished. The study doctors will check for
more medical problems. Other checks will include physical exams, laboratory tests and vital
signs. People will also have an ECG.
After this, people will visit the clinic for a check-up several times. The number of visits
and checks done at each visit will depend on the health of each person and whether they
completed their treatment or not.