Clinical trial · Interventional
Study of ES414 in Metastatic Castration-Resistant Prostate Cancer
A Phase 1 Study of ES414 in Patients Wtih 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
Summary
Brief summary (as posted)
The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of ES414.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ES414 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ES414
- description
- Cohorts 1-3 of the dose escalation stage of the study (Stage 1) will test weekly doses of 0.2 mcg/kg to 2 mcg/kg. Cohorts 4-9 of the dose escalation stage of the study (Stage 1) will test continuous infusion at flat doses of 25 mcg to 300 mcg per day delivered continuously over 24 hours. The maximum tolerated dose from Stage 1 of the study will be further examined in Stage 2. Patients in cohorts 1-3 will receive ES414 weekly via intravenous (IV) infusion during the first three 28-day cycles and then on Day 1 and 15 of each subsequent cycle until disease progression, intolerable toxicity occurs, or the patient withdraws consent. Patients in cohorts 4-9 will receive ES414 as a continuous IV infusion for 6 months until disease progression, intolerable toxicity occurs, or the patient withdraws consent.
- interventionNames
- Biological: ES414
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of ES414
- timeFrame
- during first 28 days of treatment
- description
- Identify the maximum tolerated dose in dose-escalation stage (Stage 1) by assessment of dose-limiting toxicities
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate. No evidence of neuroendocrine differentiation or small cell features. * Surgically or medically castrated, with testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L). * Progressive prostate cancer by either serum PSA levels, soft tissue or bone disease as defined by the PCWG2 criteria. * In Stage 1, patients may or may not have received prior chemotherapy for mCRPC. In Stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mCRPC. Any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of ES414. Additionally, in countries where abiraterone or enzalutamide are commercially available, patients in Stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry. * ECOG ≤ 1 * Life expectancy \> 6 months per investigator * Adequate hematologic, renal, and hepatic parameters Exclusion Criteria: * Any chemotherapy, sipuleucel-T, or investigational drug in prior 4 weeks, or abiraterone or enzalutamide in prior 2 week * Any radiation therapy in prior 2 weeks * Any prior therapy targeted against PSMA * History of seizures * History of central nervous system metastasis * History of nephrotic syndrome * Spot urine total protein:creatinine ratio \>1,000 mg/gm * Planned palliative procedures for alleviation of bone pain * Active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks. * Any prednisone (or equivalent corticosteroids) use within 2 weeks of study entry * Chronic immunosuppressive therapy * Known history of HIV, hepatitis B, or hepatitis C infection * Evidence of severe or uncontrolled systemic diseases * History of bleeding disorders or thromboembolic events in prior 3 months
References
Publications (0)
Data not yet available