This study is a companion to the SYNERGY-201 clinical trial (NCT06228053), which investigates SX-682 and enzalutamide in individuals with prostate cancer. Individuals must be participating in SYNERGY-201 in order to participate in this study. The purpose of this companion study is to learn more about biomarkers, particularly a biomarker called CXCR2, and investigate if CXCR2 can predict who will receive benefit from the SYNERGY-201 drug combination. This study will also investigate how CXCR2 and other biomarkers change over time when participants receive the SYNERGY-201 drug combination. CXCR2 is of particular interest because the SYNERGY-201 drug, SX-682, inhibits CXCR2. After participants provide consent, blood samples will be collected for research purposes at three SYNERGY-201 visits (Baseline, Cycle 3 Day 1 and End of Study Drug). Up to 20 participants will also receive tumor biopsies at the Baseline and SYNERGY-201 Cycle 3 Day 1 visits. Clinical and study data collected as part of SYNERGY-201 will also be used for this study.
Study Type
OBSERVATIONAL
Enrollment
48
CXCR2 biomarker expression will be measured in tumor and immune cell samples
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGRogel Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGUniversity of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
RECRUITINGNumber of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB)
The association between tumor CXCR2 (dichotomized as absent or present CXCR2 levels in tumor at baseline as compared to negative control tissue) and CB will be measured using an odds ratio with 95% CI.
Time frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days)
Number of participants with Immune cell CXCR2 biomarker expression associated with clinical benefit (CB)
The association between immune cell CXCR2 (dichotomized as present or absent in any myeloid immune cell subset) and CB will be measured using an odds ratio with 95% CI.
Time frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days)
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