Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer (EPI-7386)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04421222 |
Recruitment Status :
Recruiting
First Posted : June 9, 2020
Last Update Posted : September 20, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: EPI-7386 (QD) Drug: EPI-7386 (BID) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer |
Actual Study Start Date : | June 23, 2020 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
200 mg EPI-7386
|
Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386 |
Experimental: Cohort 2
400 mg EPI-7386
|
Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386 |
Experimental: Cohort 3
600 mg EPI-7386
|
Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386 |
Experimental: Cohort 4
800 mg EPI-7386
|
Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386 |
Experimental: Cohort 5
1000 mg EPI-7386
|
Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386 |
Experimental: Cohort 6
800 mg EPI-7386
|
Drug: EPI-7386 (BID)
Twice daily oral dose of EPI-7386 |
- The primary safety variable for Part 1a of the study is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing). [ Time Frame: 5 months ]The DLTs will be characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE version 5.0]), timing, seriousness, and relationship to study drug.
- The primary efficacy variable for Part 1b of the study is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% at any time point during daily dosing with EPI-7386. [ Time Frame: 5 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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 (maximum 3 prior approved systemic therapies for mCRPC).
- 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.
- Presence of metastasis to soft-tissue other than lymph nodes.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421222
Contact: Karen Villaluna | 650-449-8400 | kvillaluna@essapharma.com |
United States, Florida | |
Hematology Oncology Associates of the Treasure Coast | Recruiting |
Port Saint Lucie, Florida, United States, 34952 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine in St. Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, Nevada | |
Comprehensive Cancer Center of NV Las Vegas | Recruiting |
Las Vegas, Nevada, United States, 89169 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Canada, British Columbia | |
BC Cancer | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 |
Responsible Party: | ESSA Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04421222 |
Other Study ID Numbers: |
EPI-7386-CS-001 |
First Posted: | June 9, 2020 Key Record Dates |
Last Update Posted: | September 20, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |