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.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.