Condition: Prostate Cancer · Sponsor: ESSA Pharmaceuticals
This is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. Phase 1 of the study will be a single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide. This portion of the study will primarily evaluate the safety and tolerability of the drug combination and establish the RP2CDs for EPI-7386 and enzalutamide when dosed in combination. In addition, blood sampling will be conducted for PK evaluation to assess the potential DDI between the two drugs. Once the RP2CD for each drug has been established, Phase 2 of the study will commence. Phase 2 is a two-arm, randomized (2:1), open-label study. Approximately 120 subjects will be randomized 2:1 to: * Group 1: EPI-7386 at the RP2CD + enzalutamide(depending on the results of the Phase 1) (n=80) * Group 2: Enzalutamide single agent (n=40) The planned dose of enzalutamide and EPI-7386 for the combination arm will be those determined in the Phase 1 of this study based on safety and exposure data. Subjects may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or PCWG3.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Arizona Urology | Tucson, Arizona, United States | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie, Florida, United States | — |
| Moffitt Cancer Center | Tampa, Florida, United States | — |
| Chesapeake Urology Associates | Baltimore, Maryland, United States | — |
| Johns Hopkins University | Baltimore, Maryland, United States | — |
| Washington University Siteman Cancer Center | St Louis, Missouri, United States | — |
| Urology Cancer Center | Omaha, Nebraska, United States | — |
| Great Lakes Cancer Center | Buffalo, New York, United States | — |
| Roswell Park Comprehensive Cancer Center | Buffalo, New York, United States | — |
| Memorial Sloan Kettering Cancer Center | New York, New York, United States | — |
| OHSU Knight Cancer Instititue | Portland, Oregon, United States | — |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina, United States | — |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05075577