Overview

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386.

Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects.

There are other important things that will be evaluated during the study:

• How the amount of EPI-7386 in the blood changes over time.
• The effect of EPI-7386 on prostate cancer.
• The effect of EPI-7386 on certain substances in the body.
• The possibility that EPI-7386 can interact with other drugs.

Eligibility

Inclusion Criteria:

• Male 18 years of age or older.
• Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
• Evidence of castration-resistant prostate cancer (CRPC).
• Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
• No further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician.
• Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
• The patient must have recovered from toxicities related to any prior treatments.
• Castrate at screening.
• Patients receiving bisphosphonates or other approved bone-targeting therapy must be on a stable dose for at least 4 weeks prior to the start of study drug.
• Demonstrate adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Exclusion Criteria:

• Biologic anti-cancer therapy or a cytotoxic chemotherapy within 4 weeks prior to the start of study drug.
• Use of hormonal agents with anti-tumor activity against prostate cancer within 4 weeks prior to the start of study drug.
• Intervention with any chemotherapy, investigational agents, or other anti-cancer drugs within 14 days or 5 half-lives, whichever is longer, of the first dose of study drug.
• Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study drug.
• Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study drug.
• Received a blood transfusion within 28 days of screening.
• Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 4 weeks before enrollment.
• Spinal cord compression.
• Diagnosis of another invasive malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma.
• Gastrointestinal disorder affecting absorption.
• Significant cardiovascular disease.
• Concurrent disease or any clinically significant abnormality.
• Use of compounds known to be strong inducers and strong inhibitors of CYP3A and CYP2C8 within 14 days of the first dose of study drug.
• Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6.