About the study

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. The study will be conducted in 2 parts: - Part 1a: To evaluate the safety and tolerability of EPI-7386 - Part 1b: To evaluate 2 cohorts (Cohort A and Cohort B) enrolling in parallel - Part 1b Cohort A: Will further evaluate the safety and tolerability of EPI-7386 in a patient population that has not been previously treated with chemotherapy. - Part 1b Cohort B: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (up to 12 weeks prior to the start of standard of care therapy) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Male 18 years of age or older.
2. Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
3. Evidence of castration-resistant prostate cancer (CRPC).
4. 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.
5. Limited further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician. Specifically, patients must have progressed on at least 2, but not more than 3, prior approved systemic therapies for mCRPC which include at least one, but not more than 2, second generation anti-androgen drug.
6. Patients may have received prior docetaxel for mCSPC or mCRPC but must not have had disease progression during, or within 6 months of completing chemotherapy. Only one line of prior chemotherapy is allowed.
7. Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
8. The patient must have recovered from toxicities related to any prior treatments.
9. Castrate at screening.
10. 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.
11. Demonstrate adequate organ function.
12. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Part 1b Cohort A

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.