Clinical trial · Interventional
Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-506 in Patients With Metastatic Castration-Resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At end of Phase 1 excessive high pill burden (18 capsules/day)
Summary
Brief summary (as posted)
The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II. In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Diseases, Male | — | UNRESOLVED | — |
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| Prostatic Diseases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPI-506 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EPI-506
- description
- Part I: Ascending doses of EPI-506 administered orally to define the maximum tolerated dose.
- interventionNames
- Drug: EPI-506
Primary outcomes (2)
- measure
- Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
- timeFrame
- 12 weeks
- measure
- Part II: Prostate-specific antigen (PSA) response rate
- timeFrame
- 12 weeks
Secondary outcomes (41)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the Prostate * Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI * Demonstrated progression on abiraterone and/or enzalutamide * Demonstrated PSA progression within 12 weeks of study participation * Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy * Eastern Cooperative Oncology Group (ECOG) score between 0-1 * Asymptomatic or mildly symptomatic Exclusion Criteria: * Candidates for cytotoxic chemotherapy * Received more than one line of chemotherapy * Received more than one treatment course of enzalutamide or abiraterone * Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa) * Known intra-cerebral disease or brain mets * Spinal cord compression within 6 months * Prior treatment with investigative androgen receptor (AR) agents
References
Publications (0)
Data not yet available