NCT04421222 (EPI-7386) is a Phase 1 clinical trial of EPI-7386 (QD) in Prostate Cancer, sponsored by ESSA Pharmaceuticals.

Who is sponsoring NCT04421222?

NCT04421222 is sponsored by ESSA Pharmaceuticals.

What drugs are being tested in NCT04421222?

Interventions in NCT04421222: EPI-7386 (QD), EPI-7386 (BID), Abiraterone acetate, Apalutamide.

What condition does NCT04421222 study?

NCT04421222 studies Prostate Cancer.

Is NCT04421222 still recruiting?

NCT04421222 is currently terminated. Last updated 28 February 2025.

Last reviewed 2025-02-28 · How we verify

NCT04421222: EPI-7386

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer

Terminated Phase 1 Last updated 28 February 2025

What this trial tests

Phase 1 trial testing EPI-7386 (QD) in Prostate Cancer in 71 participants. Terminated before completion.

Timeline

23 June 2020

Primary endpoint
31 October 2024

3 December 2024

Quick facts

Lead sponsor	ESSA Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	23 June 2020
Primary completion	31 October 2024
Estimated completion	3 December 2024
Sites	9 locations across Canada, United States

Drugs / interventions tested

EPI-7386 (QD)
EPI-7386 (BID) — full drug profile →
Abiraterone acetate (ABIRATERONE) — full drug profile →
Apalutamide (apalutamide) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

ESSA Pharmaceuticals — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2 Phases: * Phase 1a: Dose Escalation (mCRPC) * Phase 1b: Dose Expansion (mCRPC) * Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA): * Cohort 1: Combination with AAP in mHSPC or mCRPC patients * Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intrinsically disordered proteins and biomolecular condensates as drug targets.
Biesaga M, Frigolé-Vivas M, Salvatella X. · · 2021 · cited 100× · PMID 33812316 · DOI 10.1016/j.cbpa.2021.02.009
Second generation androgen receptor antagonists and challenges in prostate cancer treatment.
Chen Y, Zhou Q, Hankey W, Fang X, et al · · 2022 · cited 86× · PMID 35864113 · DOI 10.1038/s41419-022-05084-1
Small molecules targeting the disordered transactivation domain of the androgen receptor induce the formation of collapsed helical states.
Zhu J, Salvatella X, Robustelli P. · · 2022 · cited 71× · PMID 36302916 · DOI 10.1038/s41467-022-34077-z
Rational optimization of a transcription factor activation domain inhibitor.
Basu S, Martínez-Cristóbal P, Frigolé-Vivas M, Pesarrodona M, et al · · 2023 · cited 61× · PMID 38049566 · DOI 10.1038/s41594-023-01159-5
Androgen Receptor-Dependent Mechanisms Mediating Drug Resistance in Prostate Cancer.
Ehsani M, David FO, Baniahmad A. · · 2021 · cited 58× · PMID 33810413 · DOI 10.3390/cancers13071534
De Novo Design of an Androgen Receptor DNA Binding Domain-Targeted peptide PROTAC for Prostate Cancer Therapy.
Ma B, Fan Y, Zhang D, Wei Y, et al · · 2022 · cited 49× · PMID 35971165 · DOI 10.1002/advs.202201859
AR Splicing Variants and Resistance to AR Targeting Agents.
Kanayama M, Lu C, Luo J, Antonarakis ES, et al · · 2021 · cited 43× · PMID 34071114 · DOI 10.3390/cancers13112563
An Overview of Next-Generation Androgen Receptor-Targeted Therapeutics in Development for the Treatment of Prostate Cancer.
Mohler ML, Sikdar A, Ponnusamy S, Hwang DJ, et al · · 2021 · cited 41× · PMID 33672769 · DOI 10.3390/ijms22042124

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other ESSA Pharmaceuticals trials

Trials by the same sponsor.

NCT05075577 — EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with MCRPC · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04421222 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ESSA Pharmaceuticals
Last refreshed: 28 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04421222.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing