A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial
Syntrix Biosystems, Inc.
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
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 la…
Interventions
- DrugSX-682
Specified dose twice daily
- DrugEnzalutamide
Specified dose once daily
Locations (6)
- University of California, Los AngelesLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- University of MichiganAnn Arbor, Michigan
- University of MinnesotaMinneapolis, Minnesota
- Duke UniversityDurham, North Carolina
- University of WisconsinMadison, Wisconsin