EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With mCRPC
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
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.