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Recruiting Phase 2 NCT06228053

Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer

Trial Parameters

Condition Metastatic Castration-resistant Prostate Cancer
Sponsor Syntrix Biosystems, Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 53
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2024-11-18
Completion 2026-06-30
Interventions
SX-682Enzalutamide

Brief Summary

The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed prior therapy with androgen receptor pathway inhibitors.

Eligibility Criteria

Inclusion Criteria: 1. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures. 2. 2\. Diagnosis of mCRPC with (a) any histology, and (b) currently on or previously on abiraterone/prednisone (or abiraterone/dexamethasone) or darolutamide, apalutamide or enzalutamide with documented progression in either the mCRPC or mHSPC settings, and currently with: * rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng/mL by local testing); or * progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan; no washout necessary. 3. Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future

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