This study will test if one shot of a medicine called RE104, given in different amounts, can safely help with cancer or other illnesses who are having trouble coping and adjusting.
To join this study, you will first have a visit to see if you qualify called a screening visit. During this visit, you will have medical and mental health exams. If you join, you will be randomly placed into one of the two groups. You won’t know which group you are in and neither will the study staff. You will get one or two shots at different levels, either the 30mg or 1.5 mg. Both shots will be given in the upper arm, like a vaccine. To take part, you must come in-person for visits. These visits include medical history, physical exams, heart tests (ECG), safety checks like blood and urine tests, and mental health assessments. You will also have remote follow-up study visits for psychological tests, which will be done online or over the phone. After your shots, you must have a support person with you to help you. The screening period will take a maximum of 28 days. If you are eligible to join, the study will take 42 days. In total, you will be in the study for a maximum of 70 days.
You may be able to join if you have cancer or another serious illness like amyotrophic lateral sclerosis, multiple sclerosis, Parkinson’s disease, or idiopathic pulmonary fibrosis. If you have ongoing depression, anxiety, or feelings of hopelessness. If you can take care of yourself and have no serious organ problems, and you are 18 years old or older.
Protocol Number: 25-0813
More information available at ClinicalTrials.gov: NCT07002034
Principal Investigator