About this trial
This study is looking at how well the combination of two medicines, TVB-2640 and Enzalutamide, works for men with metastatic castration-resistant prostate cancer. This type of cancer has spread and hasn't improved with other treatments. The goal is to find out if this combination can be safely used and what effects it has. Participation in this study will last about one to two years after joining.
The trial's ID number is NCT05743621. It is a Phase 1 trial, which means it is testing how safe the treatment is and the best doses to use. This study is regulated by the FDA and plans to include about 30 participants.
Who can join
Men aged 18 and older can join this study if they have prostate cancer that has spread and is not responding to hormone therapy. They should be willing to have a tumor biopsy. Participants must not have had specific prior treatments, such as taxane chemotherapy. The study team will confirm who is eligible before they can join.
Condition
Prostatic Neoplasms, Castration-Resistant
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
All participants will receive Enzalutamide first for 28 days. After that, they will take TVB-2640 along with Enzalutamide. The dose of TVB-2640 may vary between 100 mg and 300 mg each day, based on how well it's tolerated. Everyone is part of the same group in this study, so there is no random assignment.
Where
This trial is running at 1 location in the United States. It is currently recruiting.
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York