A Phase 1 open-label, dose-finding multi-center trial of [177Lu]Ludotadipep in metastatic castration-resistant prostate cancer patients, followed by an open-label, repeat dose, multi center Phase 2a trial to assess safety and efficacy
In Phase 1 eligable patients will be injected with a single dose of [177Lu]Ludotadipep and treated with cooling treatments and an injectable amino acid treatment to prevent sideeffects. Saline Solution will be adminstered intavenously to prevent dehydration. Patients will then be monitored for 8 weeks for adverse events, Dose limiting toxicity and for clinical disease response through a number of assessments include physical excaminations, vital signs, and imaging. In Phase 2 Patients will recieve [177Lu]Ludotadipep every 8 weeks for a maximum of 6 administrations along with the same preventative precautions as in phase 1. Imaging will be done 24 hours after each administration and the subjects will be followed closely after each administration at 4 and 6 weeks after each admistration subjects will return to the CTU for follow up assessments. At the 6 week visit whether or not the subject will continue with future admistrations will be determined by the investigator based on the results of the imaging and assesments performed at follow up visits.
This is a new potential treatment for metastatic prostate cancer and disease that is prevalent in today's male veteran population. Early symptoms of the disease often go unnoticed and due to this by the time of diagnosis prostate cancer is typically in it's advanced stages. Ludotidapep is a new proposed treatment of metastatic prostate cancer that has a longer uptake time and half life to for more thorough uptake by cancer cells, and is believed to have fewer side effects then more standard treatments such as chemotherapy.
This is a new potential treatment for metastatic prostate cancer and disease that is prevalent in today's male veteran population. Early symptoms of the disease often go unnoticed and due to this by the time of diagnosis prostate cancer is typically in it's advanced stages. Ludotidapep is a new proposed treatment of metastatic prostate cancer that has a longer uptake time and half life to for more thorough uptake by cancer cells, and is believed to have fewer side effects then more standard treatments such as chemotherapy.
Principal Investigator: Dr. Medhat Osman
Study Coordinator: Brittany Minor
This study is currently enrolling. To learn more about Future Chem and how you can join contact our research office at (314) 289-7690.
This study is funded by the Foundation through the sponsor FutureChem Co
Study Coordinator: Brittany Minor
This study is currently enrolling. To learn more about Future Chem and how you can join contact our research office at (314) 289-7690.
This study is funded by the Foundation through the sponsor FutureChem Co