drugset / Trial / NCT05743621

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

NCT05743621

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.

Timeline

Start
2023-11-20
Primary completion
2027-01-25
Completion
2029-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Denifanstat Small molecule 100 mg Oral
Subject Denifanstat Small molecule 150 mg Oral
Subject Denifanstat Small molecule 200 mg Oral
Subject Denifanstat Small molecule 250 mg Oral
Subject Denifanstat Small molecule 300 mg Oral
Subject Enzalutamide Other / unclassified 160 mg Oral