Clinical trial · Interventional
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of 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): Business Decision due to insufficient enrollment
Summary
Brief summary (as posted)
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone and Prednisone | Drug | — | UNRESOLVED |
| Dutasteride 0.5 mg | Drug | — | UNRESOLVED |
| PCUR-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PCUR-101 Dose Escalation
- description
- PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase
- interventionNames
- Drug: PCUR-101
- type
- EXPERIMENTAL
- label
- PCUR-101 Dose Expansion Cohort 1
- description
- PCUR-101 dosed orally once per day in 28 day cycles
- interventionNames
- Drug: PCUR-101
- type
- EXPERIMENTAL
- label
- PCUR-101 Dose Expansion Cohort 2
- description
- PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * Demonstrates metastatic CRPC * Castrate level of serum testosterone at screening * Adequate hematologic, renal, and hepatic function * ECOG status ≤1 * Life expectancy of at least 3 months * No more than one prior course of cytotoxic chemotherapy Exclusion Criteria: * Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology * Visceral metastasis excluding lymph nodes * Use of opiate analgesics for prostate cancer pain or non-cancer pain * other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks * History of bleeding disorder * History of seizure disorder * Concomitant use of warfarin * Prior exposure to PCUR-101 * History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia * Received wide-field external beam radiation therapy within 4 weeks * Moderate to severe neuropathy
References
Publications (0)
Data not yet available