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NCT05295927
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Phase 1 trial testing EPI-7386 in Prostatic Neoplasms in 3 participants. Terminated before completion.
30 September 2022
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 23 March 2022 |
| Primary completion | 30 September 2022 |
| Estimated completion | 30 September 2022 |
| Sites | 4 locations across Canada, United States |
Drugs / interventions tested
- EPI-7386 — full drug profile →
- Abiraterone Acetate (ABIRATERONE) — full drug profile →
- Prednisone or Prednisolone
- Apalutamide (apalutamide) — full drug profile →
Conditions studied
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
18 and older, any sex, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Natural Products Targeting the Androgen Receptor Signaling Pathway: Therapeutic Potential and Mechanisms.
Wu S, Oceguera Nava EI, Ashong D, Chen G, et al · · 2025 · PMID 41020902 · DOI 10.3390/cimb47090780
Verify or expand the search:
- PubMed search for NCT05295927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EPI-7386
Trials testing the same drug.
- NCT06312670 — Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer · Phase 2 · completed
Other recruiting trials for Prostatic Neoplasms
Currently open trials in the same condition.
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
- NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05295927 (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 Janssen Research & Development, LLC
- Last refreshed: 3 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/NCT05295927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing